Operationalising a conceptual framework for a contiguous hospitalisation episode to study associations between surgical timing and death after first hip fracture: a Canadian observational study.

OBJECTIVE: We describe steps to operationalise a published conceptual framework for a contiguous hospitalisation episode using acute care hospital discharge abstracts. We then quantified the degree of bias induced by a first abstract episode, which does not account for hospital transfers. DESIGN: Retrospective observational study. SETTING: All acute care hospitals in nine Canadian provinces. PARTICIPANTS: We retrieved acute hospitalisation discharge abstracts for 189 448 patients aged 65 years and older admitted to acute care with hip fracture between 2003 and 2013. PRIMARY AND SECONDARY OUTCOME MEASURES: The percentage of patients treated surgically, delayed to surgery (defined as two or more days after admission) and dying, between contiguous hospitalisation episodes and the first abstract episodes of care. RESULTS: Using contiguous hospitalisation episodes, 91.6% underwent surgery, 35.7% were delayed two or more days after admission and 6.7% died postoperatively, whereas, using the first abstract only, these percentages were 83.7%, 32.5% and 6.5%, respectively. CONCLUSION: We demonstrate that not accounting for hospital transfers when evaluating the association between surgical timing and death underestimates reporting of the percentage of patients treated surgically and delayed to surgery by 9%, and the percentage who die after surgery by 3%. Researchers must be aware of this potential and avoidable bias as, depending on the purpose of the study, erroneous inferences may be drawn.

Usability of a new disposable autoinjector platform device: results of a formative study conducted with a broad user population.

This article presents a late-stage formative usability study of an autoinjector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. Previous usability work on autoinjectors reported in the literature has been specific to single indications. This study was instead conducted with a broad user population, defined to represent user characteristics across a range of indications. The goals of the study were to evaluate whether users could use the devices safely and effectively, and could understand the instructions for use (IFU) as well as the accompanying training. Further objectives were to capture any usability issues and to obtain participants' subjective ratings on the IFU and training as well as the confidence and comfort in using the device. A total of 43 participants in 5 groups received training and performed simulated injections either into an injection pad or a mannequin. All participants were able to successfully use the device. The device was well appreciated by all users, with a reported degree of confidence in using the device of 98%, of user comfort of 93%, and of comprehensibility of IFU and training of 98%. These values are higher than other comparable results reported in the literature. The presence of both audible and visible feedback during injection was seen to be a significant factor contributing to injection success. The observation that the device can be safely and efficiently used by all tested user groups provides confidence that the device and IFU in their current form will pass future summative testing in specific applications.

Usability of devices for self-injection: results of a formative study on a new disposable pen injector.

This article presents a late-stage formative usability study of a pen-injector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The study was conducted with a broad user population, defined to represent user characteristics across a range of indications. The goals of the study were to confirm that the pen could be used without recurring patterns of use errors leading to hazardous situations, to evaluate the comprehension of the instructions for use (IFU), and to determine if training is necessary. In the study, a total of 36 participants in six groups (health care providers, caregivers, adolescents, diabetics with retinopathy, diabetics with neuropathy, and patients with arthritis) each read the IFU, prepared the device, and performed two simulated injections into an injection pad. Any use errors, near misses, or deviations from the IFU procedure were recorded. The overall success rate (injection completed by the participant without need for assistance) was 94% for the first and 100% for the second injection. Ninety-two percent of the participants reported that they felt confident using the device, 100% found the IFU helpful, and 75% found the device positively comfortable to use. Overall, a total average of 3.35 deviations and errors per user and injection were recorded (there were no near misses). Subtracting the errors without any potential for negative consequences for the injection or the user (trivial deviations), as well as those related to attaching and removing the pen needle (independent of the design of the pen itself), led to an average of 1.31 potentially relevant deviations per user and injection. It was concluded that the pen injector together with the IFU could be safely and efficiently used by all user groups without any training, and thus that the device and IFU in their current form are well suited for use in a range of specific applications.

Significant event analysis: a comparative study of knowledge, process and attitudes in primary care.

INTRODUCTION: Significant event analysis (SEA) is now well established in UK primary care. Previously, considerable variation has been reported in the knowledge, skills and attitudes of general practitioners undertaking SEA. Little is known about the wider team's understanding, participation or perceptions. We therefore aimed to determine the awareness, degree of analysis and perceived risk of recurrence of a recent significant event, types of discussion forums, staff groups' participation and perceived barriers. Comparisons were made with a 2003 survey and significant changes described. METHOD: A postal questionnaire survey was undertaken of a random selection of general practice team members in National Health Service Greater Glasgow in 2008/9. RESULTS: In total, 375/711 respondents (53%) from 111 practices participated. The vast majority was aware of a recent significant event, 29% reported not implementing a change and 23% perceived the risk of recurrence as moderate to high. Administrative and community-based staff were infrequently involved in meetings. Dedicated significant event meetings remain uncommon (P = 0.06). Perceptions improved since 2003, but lack of time remained a concern. DISCUSSION: This survey was the first known attempt to include all members of the primary care team while studying SEA. Awareness and analysis levels were high, but only lead to sustainable improvement of care quality and clinical safety if teams implement change. Greater use should be made of dedicated SEA meetings and participation of all staff groups increased to gain full benefits. Lack of time can be managed pragmatically by prioritizing events based on their perceived severity, potential for change and potential team involvement.

A review of significant events analysed in general practice: implications for the quality and safety of patient care.

BACKGROUND: Significant event analysis (SEA) is promoted as a team-based approach to enhancing patient safety through reflective learning. Evidence of SEA participation is required for appraisal and contractual purposes in UK general practice. A voluntary educational model in the west of Scotland enables general practitioners (GPs) and doctors-in-training to submit SEA reports for feedback from trained peers. We reviewed reports to identify the range of safety issues analysed, learning needs raised and actions taken by GP teams. METHOD: Content analysis of SEA reports submitted in an 18 month period between 2005 and 2007. RESULTS: 191 SEA reports were reviewed. 48 described patient harm (25.1%). A further 109 reports (57.1%) outlined circumstances that had the potential to cause patient harm. Individual 'error' was cited as the most common reason for event occurrence (32.5%). Learning opportunities were identified in 182 reports (95.3%) but were often non-specific professional issues not shared with the wider practice team. 154 SEA reports (80.1%) described actions taken to improve practice systems or professional behaviour. However, non-medical staff were less likely to be involved in the changes resulting from event analyses describing patient harm (p < 0.05) CONCLUSION: The study provides some evidence of the potential of SEA to improve healthcare quality and safety. If applied rigorously, GP teams and doctors in training can use the technique to investigate and learn from a wide variety of quality issues including those resulting in patient harm. This leads to reported change but it is unclear if such improvement is sustained.