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Background Attempts to achieve digital transformation across the health service have stimulated increasingly large-scale and more complex change programmes. These encompass a growing range of functions in multiple locations across the system and may take place over extended timeframes. This calls for new approaches to evaluate these programmes. Main body Drawing on over a decade of conducting formative and summative evaluations of health information technologies, we here build on previous work detailing evaluation challenges and ways to tackle these. Important considerations include changing organisational, economic, political, vendor and markets necessitating tracing of evolving networks, relationships, and processes; exploring mechanisms of spread; and studying selected settings in depth to understand local tensions and priorities. Conclusions Decision-makers need to recognise that formative evaluations, if built on solid theoretical and methodological foundations, can help to mitigate risks and help to ensure that programmes have maximum chances of success.

Background The aim of this systematic review was to synthesise peer-reviewed literature assessing the impact of electronic prescribing (eP) systems on the working practices of healthcare professionals (HCPs) in the inpatient setting and identify implications for practice and research. Methods We searched PubMed, Medline, Embase, Cochrane and the Cumulative Index to Nursing Allied Health Literature databases for studies published from inception to November 2018. We included controlled, uncontrolled, observational and descriptive studies that explored the effect of eP on HCPs’ working practices in an inpatient setting. Data on setting, eP system and impact on working practices were extracted. Methodological quality was assessed using the Mixed Methods Appraisal Tool. Emergent themes were identified and subjected to narrative synthesis. The protocol was registered with PROSPERO (registration CRD42017075804). Results Searches identified 1301 titles and abstracts after duplicate removal. 171 papers underwent full-text review. A total of 25 studies met the inclusion criteria, from nine different countries. Nineteen were of commercial eP systems. There were a range of study designs; most (n = 14) adopted quantitative methods such as cross-sectional surveys, ten adopted qualitative approaches and a further one used mixed methods. Fourteen of the 25 studies were deemed to be of high quality. Four key themes were identified: communication, time taken to complete tasks, clinical workflow, and workarounds. Within each theme, study findings differed as to whether the effects of eP on HCPs’ working practices were positive or negative. Conclusion There is a lack of consensus within the literature on the impact of eP on HCPs’ working practices. Future research should explore the strategies resulting in a positive impact on HCPs’ working practices and learn from those that have not been successful.

Background A previous census of electronic prescribing (EP) systems in England showed that more than half of hospitals with EP reported more than one EP system within the same hospital. Our objectives were to describe the rationale for having multiple EP systems within a single hospital, and to explore perceptions of stakeholders about the advantages and disadvantages of multiple systems including any impact on patient safety. Methods Hospitals were selected from previous census respondents. A decision matrix was developed to achieve a maximum variation sample, and snowball sampling used to recruit stakeholders of different professional backgrounds. We then used an a priori framework to guide and analyse semi-structured interviews. Results Ten participants, comprising pharmacists and doctors and a nurse, were interviewed from four hospitals. The findings suggest that use of multiple EP systems was not strategically planned. Three co-existing models of EP systems adoption in hospitals were identified: organisation-led, clinician-led and clinical network-led, which may have contributed to multiple systems use. Although there were some perceived benefits of multiple EP systems, particularly in niche specialities, many disadvantages were described. These included issues related to access, staff training, workflow, work duplication, and system interfacing. Fragmentation of documentation of the patient’s journey was a major safety concern. Discussion The complexity of EP systems’ adoption and deficiencies in IT strategic planning may have contributed to multiple EP systems use in the NHS. In the near to mid-term, multiple EP systems may remain in place in many English hospitals, which may create challenges to quality and patient safety. Electronic supplementary material The online version of this article (10.1186/s12913-018-3750-1) contains supplementary material, which is available to authorized users.

Background Adverse drug reactions, poor patient adherence and errors, here collectively referred to as medication-related harm (MRH), cause around 2.7-8.0% of UK hospital admissions. Communication gaps between successive healthcare providers exist, but little is known about how MRH is recorded in inpatients’ medical records. We describe the presence and quality of MRH documentation for patients admitted to a London teaching hospital due to MRH. Additionally, the international classification of disease 10th revision (ICD-10) codes attributed to confirmed MRH-related admissions were studied to explore appropriateness of their use to identify these patients. Methods Clinical pharmacists working on an admissions ward in a UK hospital identified patients admitted due to suspected MRH. Six different data sources in each patient’s medical record, including the discharge summary, were subsequently examined for MRH-related information. Each data source was examined for statements describing the MRH: symptom and diagnosis, identification of the causative agent, and a statement of the action taken or considered. Statements were categorised as ‘explicit’ if unambiguous or ‘implicit’ if open to interpretation. ICD-10 codes attributed to confirmed MRH cases were recorded. Results Eighty-four patients were identified over 141 data collection days; 75 met our inclusion criteria. MRH documentation was generally present (855 of 1307 statements were identified; 65%), and usually explicit (705 of 855; 82%). The causative agent had the lowest proportion of explicit statements (139 of 201 statements were explicit; 69%). For two (3%) discharged patients, the causal agent was documented in their paper medical record but not on the discharge summary. Of 64 patients with a confirmed MRH diagnosis at discharge, only six (9%) had a MRH-related ICD-10 code. Conclusions Availability of information in the paper medical record needs improving and communication of MRH-related information could be enhanced by using explicit statements and documenting reasons for changing medications. ICD-10 codes underestimate the true occurrence of MRH.

Background Systems and processes for prescribing, supplying and administering inpatient medications can have substantial impact on medication administration errors (MAEs). However, little is known about the medication systems and processes currently used within the English National Health Service (NHS). This presents a challenge for developing NHS-wide interventions to increase medication safety. We therefore conducted a cross-sectional postal census of medication systems and processes in English NHS hospitals to address this knowledge gap. Methods The chief pharmacist at each of all 165 acute NHS trusts was invited to complete a questionnaire for medical and surgical wards in their main hospital (July 2011). We report here the findings relating to medication systems and processes, based on 18 closed questions plus one open question about local medication safety initiatives. Non-respondents were posted another questionnaire (August 2011), and then emailed (October 2011). Results One hundred (61% of NHS trusts) questionnaires were returned. Most hospitals used paper-based prescribing on the majority of medical and surgical inpatient wards (87% of hospitals), patient bedside medication lockers (92%), patients’ own drugs (89%) and ‘one-stop dispensing’ medication labelled with administration instructions for use at discharge as well as during the inpatient stay (85%). Less prevalent were the use of ward pharmacy technicians (62% of hospitals) or pharmacists (58%) to order medications on the majority of wards. Only 65% of hospitals used drug trolleys; 50% used patient-specific inpatient supplies on the majority of wards. Only one hospital had a pharmacy open 24 hours, but all had access to an on-call pharmacist. None reported use of unit-dose dispensing; 7% used an electronic drug cabinet in some ward areas. Overall, 85% of hospitals had a double-checking policy for intravenous medication and 58% for other specified drugs. “Do not disturb” tabards/overalls were routinely used during nurses’ drug rounds on at least one ward in 59% of hospitals. Conclusions Inter- and intra-hospital variations in medication systems and processes exist, even within the English NHS; future research should focus on investigating their potential effects on nurses’ workflow and MAEs, and developing NHS-wide interventions to reduce MAEs.

Background Failure Mode and Effects Analysis (FMEA) is a prospective risk assessment tool that has been widely used within the aerospace and automotive industries and has been utilised within healthcare since the early 1990s. The aim of this study was to explore the validity of FMEA outputs within a hospital setting in the United Kingdom. Methods Two multidisciplinary teams each conducted an FMEA for the use of vancomycin and gentamicin. Four different validity tests were conducted: · Face validity: by comparing the FMEA participants’ mapped processes with observational work. · Content validity: by presenting the FMEA findings to other healthcare professionals. · Criterion validity: by comparing the FMEA findings with data reported on the trust’s incident report database. · Construct validity: by exploring the relevant mathematical theories involved in calculating the FMEA risk priority number. Results Face validity was positive as the researcher documented the same processes of care as mapped by the FMEA participants. However, other healthcare professionals identified potential failures missed by the FMEA teams. Furthermore, the FMEA groups failed to include failures related to omitted doses; yet these were the failures most commonly reported in the trust’s incident database. Calculating the RPN by multiplying severity, probability and detectability scores was deemed invalid because it is based on calculations that breach the mathematical properties of the scales used. Conclusion There are significant methodological challenges in validating FMEA. It is a useful tool to aid multidisciplinary groups in mapping and understanding a process of care; however, the results of our study cast doubt on its validity. FMEA teams are likely to need different sources of information, besides their personal experience and knowledge, to identify potential failures. As for FMEA’s methodology for scoring failures, there were discrepancies between the teams’ estimates and similar incidents reported on the trust’s incident database. Furthermore, the concept of multiplying ordinal scales to prioritise failures is mathematically flawed. Until FMEA’s validity is further explored, healthcare organisations should not solely depend on their FMEA results to prioritise patient safety issues.

Background In Britain over 39,000 reports were received by the National Patient Safety Agency relating to failures in documentation in 2007 and the UK Health Services Journal estimated in 2008 that over a million hospital outpatient visits each year might take place without the full record available. Despite these high numbers, the impact of missing clinical information has not been investigated for hospital outpatients in the UK. Studies in primary care in the USA have found 13.6% of patient consultations have missing clinical information, with this adversely affecting care in about half of cases, and in Australia 1.8% of medical errors were found to be due to the unavailability of clinical information. Our objectives were to assess the frequency, nature and potential impact on patient care of missing clinical information in NHS hospital outpatients and to assess the principal causes. This is the first study to present such figures for the UK and the first to look at how clinicians respond, including the associated impact on patient care. Methods Prospective descriptive study of missing information reported by surgeons, supplemented by interviews on the causes. Data were collected by surgeons in general, gastrointestinal, colorectal and vascular surgical clinics in three teaching hospitals across the UK for over a thousand outpatient appointments. Fifteen interviews were conducted with those involved in collating clinical information for these clinics. The study had ethics approval (Hammersmith and Queen Charlotte's & Chelsea Research Ethics Committee), reference number (09/H0707/27). Participants involved in the interviews signed a consent form and were offered the opportunity to review and agree the transcript of their interview before analysis. No patients were involved in this research. Results In 15% of outpatient consultations key items of clinical information were missing. Of these patients, 32% experienced a delay or disruption to their care and 20% had a risk of harm. In over half of cases the doctor relied on the patient for the information, making a clinical decision despite the information being missing in 20% of cases. Hospital mergers, temporary staff and non-integrated IT systems were contributing factors. Conclusions If these findings are replicated across the NHS then almost 10 million outpatients are seen each year without key clinical information, creating over a million unnecessary appointments, and putting nearly 2 million patients at risk of harm. There is a need for a systematic, regular audit of the prevalence of missing clinical information. Only then will we know the impact on clinical decision making and patient care of new technology, service reorganisations and, crucially given the present financial climate, temporary or reduced staffing levels. Further research is needed to assess the relationship between missing clinical information and diagnostic errors; to examine the issue in primary care; and to consider the patients perspective.

Background Quantitative prospective methods are widely used to evaluate the impact of new technologies such as electronic prescribing (eP) on medication errors. However, they are labour-intensive and it is not always feasible to obtain pre-intervention data. Our objective was to compare the eP medication error picture obtained with retrospective quantitative and qualitative methods. Methods The study was carried out at one English district general hospital approximately two years after implementation of an integrated electronic prescribing, administration and records system. Quantitative: A structured retrospective analysis was carried out of clinical records and medication orders for 75 randomly selected patients admitted to three wards (medicine, surgery and paediatrics) six months after eP implementation. Qualitative: Eight doctors, 6 nurses, 8 pharmacy staff and 4 other staff at senior, middle and junior grades, and 19 adult patients on acute surgical and medical wards were interviewed. Staff interviews explored experiences of developing and working with the system; patient interviews focused on experiences of medicine prescribing and administration on the ward. Interview transcripts were searched systematically for accounts of medication incidents. A classification scheme was developed and applied to the errors identified in the records review. Results The two approaches produced similar pictures of the drug use process. Interviews identified types of error identified in the retrospective notes review plus two eP-specific errors which were not detected by record review. Interview data took less time to collect than record review, and provided rich data on the prescribing process, and reasons for delays or non-administration of medicines, including "once only" orders and "as required" medicines. Conclusions The qualitative approach provided more understanding of processes, and some insights into why medication errors can happen. The method is cost-effective and could be used to supplement information from anonymous error reporting schemes.