Quality and Safety in Health Care Journal

Digitalisation of medicines: artefact, architecture and time

Digitalization:  ‘The encoding of analogue information into a digital format and the possible subsequent reconfigurations of the socio-technical context of production and consumption of the associated products and services’.1

This edition includes two papers reporting research from a 5-year study of electronic prescribing in English hospitals.2 3 The papers each address a significant safety and quality issue drawing data from the wider study. These issues are the level of coordination and integration that electronic prescribing systems achieve,3 and the emergence of ‘workarounds’ as managers and clinical users adapt electronic prescribing systems’ capabilities to their needs and working environment.2 The risks to patient safety posed by these systems, their implementation and use are further explored in a third associated paper published elsewhere.4

Workarounds were found to be either ‘informal’ or ‘formalised’ practices, the former derived from user...

When patient-centred care is worth doing well: informed consent or shared decision-making

High quality care is patient-centred.1 Efforts to promote patient-centred care in clinical practice should improve quality. Both shared decision-making (SDM) and the process of obtaining informed consent could be expressions of patient-centred care—to the extent that they respond to the advocates' call for ‘nothing about me without me’. In this issue of BMJ Quality and Safety, Shahu et al2 discuss variations in the quality of informed consent procedures, which could, in their view, fail to support patient-centred care in general, and SDM specifically.

Readers interested in advancing this domain of quality may, therefore, be interested in improving the quality of informed consent procedures and promoting the implementation and routine use of SDM. But are these similar practices? Is informed consent a lesser version of SDM, with SDM the ideal expression of patient autonomy and involvement? Or are these different in purpose, process and outcomes?


Nursing skill mix and patient outcomes

In hospitals, the nursing staff typically represent the largest single element of cost, and nursing is frequently treated as a cost centre rather than a core service line. Efforts to contain hospital costs often involve cutting nursing care, reducing the number of nurses or replacing some professional nursing staff with staff such as licensed practical nurses, nurses' aides and other assistive personnel.

Substantial evidence from studies in the USA, Europe and other countries relates lower nurse staffing and higher nurse workloads to adverse patient outcomes such as mortality, infections, falls and longer lengths of stay. Longer stays, which increase hospital costs, may result from increased adverse events lengthening admissions or delays in care due to nurses being unable to complete their work or prepare patients for discharge.1–13

Safety risks associated with the lack of integration and interfacing of hospital health information technologies: a qualitative study of hospital electronic prescribing systems in England


Substantial sums of money are being invested worldwide in health information technology. Realising benefits and mitigating safety risks is however highly dependent on effective integration of information within systems and/or interfacing to allow information exchange across systems. As part of an English programme of research, we explored the social and technical challenges relating to integration and interfacing experienced by early adopter hospitals of standalone and hospital-wide multimodular integrated electronic prescribing (ePrescribing) systems.


We collected longitudinal qualitative data from six hospitals, which we conceptualised as case studies. We conducted 173 interviews with users, implementers and software suppliers (at up to three different times), 24 observations of system use and strategic meetings, 17 documents relating to implementation plans, and 2 whole-day expert round-table discussions. Data were thematically analysed initially within and then across cases, drawing on perspectives surrounding information infrastructures.


We observed that integration and interfacing problems obstructed effective information transfer in both standalone and multimodular systems, resulting in threats to patient safety emerging from the lack of availability of timely information and duplicate data entry. Interfacing problems were immediately evident in some standalone systems where users had to cope with multiple log-ins, and this did not attenuate over time. Multimodular systems appeared at first sight to obviate such problems. However, with these systems, there was a perceived lack of data coherence across modules resulting in challenges in presenting a comprehensive overview of the patient record, this possibly resulting from the piecemeal implementation of modules with different functionalities. Although it was possible to access data from some primary care systems, we found poor two-way transfer of data between hospitals and primary care necessitating workarounds, which in turn led to the opportunity for new errors associated with duplicate and manual information transfer. Extending ePrescribing to include modules with other clinically important information needed to support care was still an aspiration in most sites, although some advanced multimodular systems had begun implementing this functionality. Multimodular systems were, however, seen as being difficult to interface with external systems.


The decision to pursue a strategy of purchasing standalone systems and then interfacing these, or one of buying hospital-wide multimodular systems, is a pivotal one for hospitals in realising the vision of achieving a fully integrated digital record, and this should be predicated on a clear appreciation of the relative trade-offs between these choices. While multimodular systems offered somewhat better usability, standalone systems provided greater flexibility and opportunity for innovation, particularly in relation to interoperability with external systems and in relation to customisability to the needs of different user groups.

Workarounds to hospital electronic prescribing systems: a qualitative study in English hospitals


Concerns with the usability of electronic prescribing (ePrescribing) systems can lead to the development of workarounds by users.


To investigate the types of workarounds users employed, the underlying reasons offered and implications for care provision and patient safety.


We collected a large qualitative data set, comprising interviews, observations and project documents, as part of an evaluation of ePrescribing systems in five English hospitals, which we conceptualised as case studies. Data were collected at up to three different time points throughout implementation and adoption. Thematic analysis involving deductive and inductive approaches was facilitated by NVivo 10.


Our data set consisted of 173 interviews, 24 rounds of observation and 17 documents. Participating hospitals were at various stages of implementing a range of systems with differing functionalities. We identified two types of workarounds: informal and formal. The former were informal practices employed by users not approved by management, which were introduced because of perceived changes to professional roles, issues with system usability and performance and challenges relating to the inaccessibility of hardware. The latter were formalised practices that were promoted by management and occurred when systems posed threats to patient safety and organisational functioning. Both types of workarounds involved using paper and other software systems as intermediaries, which often created new risks relating to a lack of efficient transfer of real-time information between different users.


Assessing formal and informal workarounds employed by users should be part of routine organisational implementation strategies of major health information technology initiatives. Workarounds can create new risks and present new opportunities for improvement in system design and integration.

Beyond hand hygiene: a qualitative study of the everyday work of preventing cross-contamination on hospital wards


Hospital-acquired infections are the most common adverse event for inpatients worldwide. Efforts to prevent microbial cross-contamination currently focus on hand hygiene and use of personal protective equipment (PPE), with variable success. Better understanding is needed of infection prevention and control (IPC) in routine clinical practice.


We report on an interventionist video-reflexive ethnography study that explored how healthcare workers performed IPC in three wards in two hospitals in New South Wales, Australia: an intensive care unit and two general surgical wards. We conducted 46 semistructured interviews, 24 weeks of fieldwork (observation and videoing) and 22 reflexive sessions with a total of 177 participants (medical, nursing, allied health, clerical and cleaning staff, and medical and nursing students). We performed a postintervention analysis, using a modified grounded theory approach, to account for the range of IPC practices identified by participants.


We found that healthcare workers' routine IPC work goes beyond hand hygiene and PPE. It also involves, for instance, the distribution of team members during rounds, the choreography of performing aseptic procedures and moving ‘from clean to dirty’ when examining patients. We account for these practices as the logistical work of moving bodies and objects across boundaries, especially from contaminated to clean/vulnerable spaces, while restricting the movement of micro-organisms through cleaning, applying barriers and buffers, and trajectory planning.


Attention to the logistics of moving people and objects around healthcare spaces, especially into vulnerable areas, allows for a more comprehensive approach to IPC through better contextualisation of hand hygiene and PPE protocols, better identification of transmission risks, and the design and promotion of a wider range of preventive strategies and solutions.

Nursing skill mix in European hospitals: cross-sectional study of the association with mortality, patient ratings, and quality of care


To determine the association of hospital nursing skill mix with patient mortality, patient ratings of their care and indicators of quality of care.


Cross-sectional patient discharge data, hospital characteristics and nurse and patient survey data were merged and analysed using generalised estimating equations (GEE) and logistic regression models.


Adult acute care hospitals in Belgium, England, Finland, Ireland, Spain and Switzerland.


Survey data were collected from 13 077 nurses in 243 hospitals, and 18 828 patients in 182 of the same hospitals in the six countries. Discharge data were obtained for 275 519 surgical patients in 188 of these hospitals.

Main outcome measures

Patient mortality, patient ratings of care, care quality, patient safety, adverse events and nurse burnout and job dissatisfaction.


Richer nurse skill mix (eg, every 10-point increase in the percentage of professional nurses among all nursing personnel) was associated with lower odds of mortality (OR=0.89), lower odds of low hospital ratings from patients (OR=0.90) and lower odds of reports of poor quality (OR=0.89), poor safety grades (OR=0.85) and other poor outcomes (0.80<OR<0.93), after adjusting for patient and hospital factors. Each 10 percentage point reduction in the proportion of professional nurses is associated with an 11% increase in the odds of death. In our hospital sample, there were an average of six caregivers for every 25 patients, four of whom were professional nurses. Substituting one nurse assistant for a professional nurse for every 25 patients is associated with a 21% increase in the odds of dying.


A bedside care workforce with a greater proportion of professional nurses is associated with better outcomes for patients and nurses. Reducing nursing skill mix by adding nursing associates and other categories of assistive nursing personnel without professional nurse qualifications may contribute to preventable deaths, erode quality and safety of hospital care and contribute to hospital nurse shortages.

Discerning quality: an analysis of informed consent documents for common cardiovascular procedures


Informed consent provides a powerful opportunity to build trust between the patient and clinician while supporting patient autonomy, transparency and shared decision-making.1 2 However, it is often relegated to a perfunctory task, performed as an ethical-legal formality minutes prior to a procedure.3–5 As such, basic elements necessary for achieving the espoused goals of informed consent may be missing or suboptimally implemented, undermining patient-centred, high-quality decision-making. The types and extent of gaps in quality have not been systematically studied, limiting efforts to improve implementation. Our aim was to assess variation in quality of informed consent documents associated with three commonly performed cardiovascular procedures: left heart catheterisation, transesophageal echocardiography and implantation of a cardioverter defibrillator. We focused on basic elements of consent documents with the goal of illuminating opportunities to establish minimum standards for informed consent.


A primer on PDSA: executing plan-do-study-act cycles in practice, not just in name


Plan-do–study–act (PDSA) cycles are the building blocks of iterative healthcare improvement.1 Although frequently regarded as separate from research,2 this quality improvement method remains rooted in the scientific method. The P in PDSA usually stands for ‘plan’ but could just as easily refer to ‘predict’. Each cycle combines prediction with a test of change (in effect, hypothesis testing), analysis and a conclusion regarding the best step forward—usually a prediction of what to do for the next PDSA cycle.3

Too often, however, improvement teams go through the motions of PDSA cycles without really embracing its spirit or applying its scientific method. For example, an improvement team might talk about having used PDSA when in reality the original change idea remained roughly unchanged throughout the project, with no refinements to the intervention or the plan to implement it. Quality improvement rarely works out so...

What we know about designing an effective improvement intervention (but too often fail to put into practice)

Intervening to change health system performance for the better

It is temptingly easy to treat improvement interventions as if they are drugs—technical, stable and uninfluenced by the environment in which they work. Doing so makes life so much easier for everyone. It allows improvement practitioners to plan their work with a high degree of certainty, funders to be confident that they know what they are buying and evaluators to focus on what really matters—whether or not ‘it’ works.

But of course most people know that life is not as simple as that. Experienced improvers have long recognised that interventions—the specific tools and activities introduced into a healthcare system with the aim of changing its performance for the better1—flex and morph. Clever improvers watch and describe how this happens. Even more clever improvers plan and actively manage the process in a way that optimises the impact of...

Microanalysis of video from the operating room: an underused approach to patient safety research

Video recording in the operating room

Video recording technologies offer a powerful way to document what happens in clinical areas.1 Cameras, and to a lesser extent, microphones, can be found in a growing number of modern operating rooms in the USA, UK and other parts of the world. While they could be used to create a detailed record of what happens in and around the operating table, this is still rarely being done; the vast majority of operations are still only documented in written operation notes. When operations are being recorded, it is primarily for educational purposes: for instance, to broadcast a live feed of a surgical demonstration to a remote audience; to provide an ‘adjunct’ to live observation;2 to collect authentic footage for edited, instructional videos on a surgical technique or procedure; to facilitate video enhanced debriefing and coaching; or to formally assess...

What can a participatory approach to evaluation contribute to the field of integrated care?

Better integration of care within the health sector and between health and social care is seen in many countries as an essential way of addressing the enduring problems of dwindling resources, changing demographics and unacceptable variation in quality of care. Current research evidence about the effectiveness of integration efforts supports neither the enthusiasm of those promoting and designing integrated care programmes nor the growing efforts of practitioners attempting to integrate care on the ground. In this paper we present a methodological approach, based on the principles of participatory research, that attempts to address this challenge. Participatory approaches are characterised by a desire to use social science methods to solve practical problems and a commitment on the part of researchers to substantive and sustained collaboration with relevant stakeholders. We describe how we applied an emerging practical model of participatory research, the researcher-in-residence model, to evaluate a large-scale integrated care programme in the UK. We propose that the approach added value to the programme in a number of ways: by engaging stakeholders in using established evidence and with the benefits of rigorously evaluating their work, by providing insights for local stakeholders that they were either not familiar with or had not fully considered in relation to the development and implementation of the programme and by challenging established mindsets and norms. While there is still much to learn about the benefits and challenges of applying participatory approaches in the health sector, we demonstrate how using such approaches have the potential to help practitioners integrate care more effectively in their daily practice and help progress the academic study of integrated care.

Interventions to improve hospital patient satisfaction with healthcare providers and systems: a systematic review


Many hospital systems seek to improve patient satisfaction as assessed by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) surveys. A systematic review of the current experimental evidence could inform these efforts and does not yet exist.


We conducted a systematic review of the literature by searching electronic databases, including MEDLINE and EMBASE, the six databases of the Cochrane Library and grey literature databases. We included studies involving hospital patients with interventions targeting at least 1 of the 11 HCAHPS domains, and that met our quality filter score on the 27-item Downs and Black coding scale. We calculated post hoc power when appropriate.


A total of 59 studies met inclusion criteria, out of these 44 did not meet the quality filter of 50% (average quality rating 27.8%±10.9%). Of the 15 studies that met the quality filter (average quality rating 67.3%±10.7%), 8 targeted the Communication with Doctors HCAHPS domain, 6 targeted Overall Hospital Rating, 5 targeted Communication with Nurses, 5 targeted Pain Management, 5 targeted Communication about Medicines, 5 targeted Recommend the Hospital, 3 targeted Quietness of the Hospital Environment, 3 targeted Cleanliness of the Hospital Environment and 3 targeted Discharge Information. Significant HCAHPS improvements were reported by eight interventions, but their generalisability may be limited by narrowly focused patient populations, heterogeneity of approach and other methodological concerns.


Although there are a few studies that show some improvement in HCAHPS score through various interventions, we conclude that more rigorous research is needed to identify effective and generalisable interventions to improve patient satisfaction.

The global burden of diagnostic errors in primary care

Diagnosis is one of the most important tasks performed by primary care physicians. The World Health Organization (WHO) recently prioritized patient safety areas in primary care, and included diagnostic errors as a high-priority problem. In addition, a recent report from the Institute of Medicine in the USA, ‘Improving Diagnosis in Health Care’, concluded that most people will likely experience a diagnostic error in their lifetime. In this narrative review, we discuss the global significance, burden and contributory factors related to diagnostic errors in primary care. We synthesize available literature to discuss the types of presenting symptoms and conditions most commonly affected. We then summarize interventions based on available data and suggest next steps to reduce the global burden of diagnostic errors. Research suggests that we are unlikely to find a ‘magic bullet’ and confirms the need for a multifaceted approach to understand and address the many systems and cognitive issues involved in diagnostic error. Because errors involve many common conditions and are prevalent across all countries, the WHO’s leadership at a global level will be instrumental to address the problem. Based on our review, we recommend that the WHO consider bringing together primary care leaders, practicing frontline clinicians, safety experts, policymakers, the health IT community, medical education and accreditation organizations, researchers from multiple disciplines, patient advocates, and funding bodies among others, to address the many common challenges and opportunities to reduce diagnostic error. This could lead to prioritization of practice changes needed to improve primary care as well as setting research priorities for intervention development to reduce diagnostic error.

Implementation and de-implementation: two sides of the same coin?

Avoiding low value care received increasing attention in many countries, as with the Choosing Wisely campaign and other initiatives to abandon care that wastes resources or delivers no benefit to patients. While an extensive literature characterises approaches to implementing evidence-based care, we have limited understanding of the process of de-implementation, such as abandoning existing low value practices. To learn more about the differences between implementation and de-implementation, we explored the literature and analysed data from two published studies (one implementation and one de-implementation) by the same orthopaedic surgeons. We defined ‘leaders’ as those orthopaedic surgeons who implemented, or de-implemented, the target processes of care and laggards as those who did not. Our findings suggest that leaders in implementation share some characteristics with leaders in de-implementation when comparing them with laggards, such as more open to new evidence, younger and less time in clinical practice. However, leaders in de-implementation and implementation differed in some other characteristics and were not the same persons. Thus, leading in implementation or de-implementation may depend to some degree on the type of intervention rather than entirely reflecting personal characteristics. De-implementation seemed to be hampered by motivational factors such as department priorities, and economic and political factors such as cost-benefit considerations in care delivery, whereas organisational factors were associated only with implementation. The only barrier or facilitator common to both implementation and de-implementation consisted of outcome expectancy (ie, the perceived net benefit to patients). Future studies need to test the hypotheses generated from this study and improve our understanding of differences between the processes of implementation and de-implementation in the people who are most likely to lead (or resist) these efforts.

Can we use patient-reported feedback to drive change? The challenges of using patient-reported feedback and how they might be addressed


The resolve to put patients at the heart of the National Health Service (NHS) has been ubiquitous in the aftermath of the Francis Report, and the policy agenda is beginning to reflect attempts to deliver that promise. The introduction of new care models at NHS ‘vanguard’ sites, the 3-year target to give all patients access to their electronic care records, and the expansion of integrated care services all exemplify the salience of patient-centricity at the national level.1 This pattern has been witnessed across many developed health systems.2

The ideals of this paradigm have also captured the attention of local commissioners and providers, offering an evolved concept of service design that resonates with patients' needs. As a result, providers are increasingly turning to patient-reported feedback to drive local improvement. This trend is indicative of progress in the field of patient experience: policy discourse has...

Patient and family empowerment as agents of ambulatory care safety and quality


Since publication of To Err is Human: Building a Safer Health System,1 consideration of medical errors and injuries has broadened beyond hospital-based harms to patient experiences of harm in primary care.2 3 The National Patient Safety Foundation (NPSF)4 has concluded that progress towards a healthcare culture of safety depends on the establishment of a systems approach that extends beyond hospitals to care settings in the community and patients' homes, herein referred to as ambulatory care settings. Included in NPSF's recommendations for such an approach is partnering with patients and families at all levels of care. Less well articulated is how this partnering may be achieved in the settings highlighted by NPSF.

The objectives of this viewpoint are twofold. The first is to hypothesise pathways through which an empowered patient–family partnership may effectively advance healthcare safety and quality in ambulatory...

Learning from near misses in aviation: so much more to it than you thought

Since its inception, the patient safety movement has been obsessed with reporting systems; roughly 20% of the To Err Is Human report1 dealt with some aspect of reporting; similarly, about 10% of the articles in BMJ Quality & Safety (and its predecessors) mention ‘reporting’ in their title, abstract or keywords. This interest sprang from an unholy trinity—an infortuitous combination of the epidemiological bent of many health professionals interested in safety, the epistemological blinders that a medical education produces2 and a kind of ‘aviation envy’—a fascination with aviation safety as an exemplar which healthcare would do well to emulate.3 But, in an all-too-common pattern in patient safety, fundamental aspects of successful safety practices in other domains were misunderstood, misapplied, mistranslated or missed altogether as health professionals encountered work whose basic assumptions are far removed from the realism and positivism of biomedicine.2

Incident reporting must result in local action

It was with great interest that we read the study of Howell and colleagues.1

In 2003, Denmark was the first country in the world to adopt a law on patient safety that obligated hospital staff to report, the hospitals to react and the National Board of Health to communicate the learning from patient safety incidents. The national reporting system was made strictly confidential, with a clear division between disciplinary and learning functions. Local data are transmitted anonymously to the national level. In 2010 and 2011, the law was expanded to cover all of healthcare, including primary care, and allowing incident reporting from patients and families.

However, recently, the Danish incident reporting system has received criticism for being too bureaucratic, and with too little learning and too few actions resulting from the more than 180 000 annual reports. Reporting in itself is time-consuming (20–30 min per report) and analysis of...

Incident reporting: rare incidents may benefit from national problem solving

We would like to congratulate the authors on the pragmatic nationwide approach that they have adopted in Denmark to address the key issues around incident reporting. Rabol and colleagues1 highlight again the challenges of collecting and meaningfully using such data.

Though experts in Denmark have drawn many of the same conclusions reached in our Delphi exercise,2 it is interesting that our findings differed on the usefulness of incident reports to detect rare events. The Danish Society concluded that rare events are difficult to detect due to deficiencies in data mining and that efforts are better spent solving known safety problems at a local level. Undoubtedly, the management of ‘big data’ is challenging, and one must consider carefully resource allocation at national and local levels. One of the initial ‘burning platforms’ driving the creation of the National Reporting and Learning System (NRLS) in England, however,...