Intravenous Chemotherapy Compounding Errors in a Follow-Up Pan-Canadian Observational Study.

PURPOSE: Intravenous (IV) compounding safety has garnered recent attention as a result of high-profile incidents, awareness efforts from the safety community, and increasingly stringent practice standards. New research with more-sensitive error detection techniques continues to reinforce that error rates with manual IV compounding are unacceptably high. In 2014, our team published an observational study that described three types of previously unrecognized and potentially catastrophic latent chemotherapy preparation errors in Canadian oncology pharmacies that would otherwise be undetectable. We expand on this research and explore whether additional potential human failures are yet to be addressed by practice standards. METHODS: Field observations were conducted in four cancer center pharmacies in four Canadian provinces from January 2013 to February 2015. Human factors specialists observed and interviewed pharmacy managers, oncology pharmacists, pharmacy technicians, and pharmacy assistants as they carried out their work. Emphasis was on latent errors (potential human failures) that could lead to outcomes such as wrong drug, dose, or diluent. RESULTS: Given the relatively short observational period, no active failures or actual errors were observed. However, 11 latent errors in chemotherapy compounding were identified. In terms of severity, all 11 errors create the potential for a patient to receive the wrong drug or dose, which in the context of cancer care, could lead to death or permanent loss of function. Three of the 11 practices were observed in our previous study, but eight were new. Applicable Canadian and international standards and guidelines do not explicitly address many of the potentially error-prone practices observed. CONCLUSION: We observed a significant degree of risk for error in manual mixing practice. These latent errors may exist in other regions where manual compounding of IV chemotherapy takes place. Continued efforts to advance standards, guidelines, technological innovation, and chemical quality testing are needed.

Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices.

BACKGROUND: Postmarket surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Little is known about factors that influence whether and how physicians report AMDEs, an essential step in developing behaviour change interventions. This study explored factors that influence AMDE reporting. METHODS: Qualitative interviews were conducted with physicians who differed by specialties that implant cardiovascular and orthopaedic devices prone to AMDEs, geography and years in practice. Participants were asked if and how they reported AMDEs, and the influencing factors. Themes were identified inductively using constant comparative technique, and reviewed and discussed by the research team on four occasions. RESULTS: Twenty-two physicians of varying specialty, region, organisation and career stage perceived AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Physician beliefs and behaviour were reinforced by limited healthcare system capacity and industry responsiveness. The healthcare system lacked processes and infrastructure to detect, capture, share and act on information about AMDEs, and constrained device choice through purchasing contracts. The device industry did not respond to reports of AMDEs from physicians or improve their products based on such reports. As a result, participants said they used devices that were less than ideal for a given patient, leading to suboptimal patient outcomes. CONCLUSIONS: There may be little point in solely educating or incentivising individual physicians to report AMDEs unless environmental conditions are conducive to doing so. Future research should explore policies that govern AMDEs and investigate how to design and implement postmarket surveillance systems.

Multiple constraints compromise decision-making about implantable medical devices for individual patients: qualitative interviews with physicians.

BACKGROUND: Little research has examined how physicians choose medical devices for treating individual patients to reveal if interventions are needed to support decision-making and reduce device-associated morbidity and mortality. This study explored factors that influence choice of implantable device from among available options. METHODS: A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites. They were asked how they decided what device to use in a given patient, sources of information they consulted, and how patients were engaged in decision-making. Sampling was concurrent with data collection and analysis to achieve thematic saturation. Data were analyzed using constant comparative technique by all members of the research team. RESULTS: Twenty-two physicians from five Canadian provinces (10 cardiovascular, 12 orthopedic; 8, 10 and 4 early, mid and late career, respectively) were interviewed. Responses did not differ by specialty, geographic region or career stage. Five major categories of themes emerged that all influence decision-making about a range of devices, and often compromise choice of the most suitable device for a given patient, potentially leading to sub-optimal clinical outcomes: lack of evidence on device performance, patient factors, physician factors, organizational and health system factors, and device and device market factors. In the absence of evidence from research or device registries, tacit knowledge from trusted colleagues and less-trusted industry representatives informed device choice. Patients were rarely engaged in decision-making. Physician preference for particular devices was a barrier to acquiring competency in devices potentially more suitable for patients. Access to suitable devices was further limited to the number of comparable devices on the market, local inventory and purchasing contract specifications. CONCLUSIONS: This study revealed that decision-making about devices is complex, cognitively challenging and constrained by several factors limiting access to and use of devices that could optimize patient outcomes. Further research is needed to assess the impact of these constraints on clinical outcomes, and develop interventions that optimize decision-making about device choice for treating given patients.

MEDICAL DEVICE RECALLS IN CANADA FROM 2005 TO 2015.

OBJECTIVES: Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace. METHODS: We used data from Health Canada to study medical device recalls in Canada from 2005 to 2015. We analyzed the risks of medical device recalls according to the risk class of the device (I lowest; IV highest) and the hazard priority of the recall (Type I highest potential harm; Type III lowest potential harm). RESULTS: During a 10-year period, there were 7,226 medical device recalls. Most recalls were for intermediate risk class (Class II, 40.1 percent; Class III, 38.7 percent) medical devices. Among recalled devices, 5.0 percent were judged to have a reasonable probability of serious adverse health consequences or death (Type I recall Hazard Priority classification). While the number of medical devices marketed in Canada is not known, over a similar 10-year period, 24,849 new Class II, II, and IV medical device licenses were issued by Health Canada. CONCLUSIONS: Several hundred medical device recalls occur in Canada each year. Further research is needed to characterize the nature of medical device recalls, and to explore how consumers use information about recalls.

Factors constraining patient engagement in implantable medical device discussions and decisions: interviews with physicians.

OBJECTIVE: Patient engagement (PE) is warranted when treatment risks and outcomes are uncertain, as is the case for higher risk medical devices. Previous research found that patients were not engaged in discussions or decisions about implantable medical devices. This study explored physician views about engaging patients in such discussions. DESIGN: Qualitative interviews using a basic descriptive approach. SETTING: Canada. PARTICIPANTS: Practicing cardiovascular and orthopaedic physicians. MAIN OUTCOME MEASURES: Level, processes and determinants of PE in medical device discussions and decisions. RESULTS: Views were largely similar among 10 cardiovascular and 12 orthopaedic physicians interviewed. Most said that it was feasible to inform and sometimes involve patients in discussions, but not to partner with them in medical device decision-making. PE was constrained by patient (comfort with PE, technical understanding, physiologic/demographic characteristics, prognosis), physician (device preferences, time), health system (purchasing contracts) and device factors (number of devices on market, comparative advantage). A framework was generated to help physicians engage patients in discussions about medical devices, even when decisions may not be preference sensitive due to multiple constraints on choice. CONCLUSIONS: This study identified that patients are not engaged in discussions or decisions about implantable medical devices. This may be due to multiple constraints. Further research should establish the legitimacy, prevalence and impact of constraining factors, and examine whether and how different levels and forms of PE are needed and feasible.

"We can't get along without each other": Qualitative interviews with physicians about device industry representatives, conflict of interest and patient safety.

OBJECTIVES: Physician relationships with device industry representatives have not been previously assessed. This study explored interactions with device industry representatives among physicians who use implantable cardiovascular and orthopedic devices to identify whether conflict of interest (COI) is a concern and how it is managed. DESIGN: A descriptive qualitative approach was used. Physicians who implant orthopedic and cardiovascular devices were identified in publicly available directories and web sites, and interviewed about their relationships with device industry representatives. Sampling was concurrent with data collection and analysis. Data were analyzed and discussed using constant comparative technique by all members of the research team. RESULTS: Twenty-two physicians (10 cardiovascular, 12 orthopedic) were interviewed. Ten distinct representative roles were identified: purchasing, training, trouble-shooting, supplying devices, assisting with device assembly and insertion, supporting operating room staff, mitigating liability, conveying information about recalls, and providing direct and indirect financial support. Participants recognized the potential for COI but representatives were present for the majority of implantations. Participants revealed a tension between physicians and representatives that was characterized as "symbiotic", but required physicians to be vigilant about COI and patient safety, particularly because representatives varied regarding disclosure of device defects. They described a concurrent tension between hospitals, whose policies and business practices were focused on cost-control, and physicians who were required to comply with those policies and use particular devices despite concerns about their safety and effectiveness. CONCLUSIONS: Given the potential for COI and threats to patient safety, further research is needed to establish the clinical implications of the role of, and relationship with device industry representatives; and whether and how hospitals do and should govern interaction with representatives, or support their staff in this regard.

Effects of Nested Interruptions on Task Resumption: A Laboratory Study With Intensive Care Nurses.

OBJECTIVE: Interruptions to secondary tasks resulting in multiple tasks to resume may tax working memory. The objective of this research is to study such interruptions experienced by intensive care unit (ICU) nurses. BACKGROUND: ICU nurses are frequently interrupted, resulting in a switch from primary to secondary tasks. In two recent studies, we observed that some of these secondary tasks also get interrupted, resulting in multiple tasks that have to be resumed, a phenomenon we refer to as nested interruptions. Although completing multiple secondary tasks in a serial fashion during an interruption period can create context-switching costs, we hypothesize that nested interruptions tax the working memory even more than just performing multiple secondary tasks sequentially because the nurse would have to encode in working memory the resumption goals for both the primary and the interrupted secondary tasks. METHOD: We conducted a laboratory study with 30 ICU nurses, who performed an electronic order-entry task under three interruption conditions: (a) baseline-no secondary task during the interruption period; (2) serial-performance of two tasks one after the other during the interruption period; and (3) nested-performance of two tasks during the interruption period, one of which was also interrupted. RESULTS: Nested interruptions resulted in significantly longer primary-task resumption lag and less accurate task resumption compared with both the serial interruption and baseline conditions. CONCLUSION: The nested nature of interruptions adds to the resumption lag and diminishes resumption accuracy by likely populating the working memory with goals associated with interrupted secondary tasks.

Meta-Review of the Quantity and Quality of Evidence for Knee Arthroplasty Devices.

INTRODUCTION: Some cardiovascular devices are licensed based on limited evidence, potentially exposing patients to devices that are not safe or effective. Research is needed to ascertain if the same is true of other types of medical devices. Knee arthroplasty is a widely-used surgical procedure yet implant failures are not uncommon. The purpose of this study was to characterize available evidence on the safety and effectiveness of knee implants. METHODS: A review of primary studies included in health technology assessments (HTA) on total (TKA) and unicompartmental knee arthroplasty (UKA) was conducted. MEDLINE, EMBASE, CINAHL, Cochrane Library and Biotechnology & BioEngineering Abstracts were searched from 2005 to 2014, plus journal tables of contents and 32 HTA web sites. Patients were aged 18 and older who underwent primary TKA or UKA assessed in cohort or randomized controlled studies. Summary statistics were used to report study characteristics. RESULTS: A total of 265 eligible primary studies published between 1986 and 2014 involving 59,217 patients were identified in 10 HTAs (2 low, 7 moderate, 1 high risk of bias). Most evaluated TKA (198, 74.5%). The quality of evidence in primary studies was limited. Most studies were industry-funded (23.8%) or offered no declaration of funding or conflict of interest (44.9%); based on uncontrolled single cohorts (58.5%), enrolled fewer than 100 patients (66.4%), and followed patients for 2 years or less (UKA: single cohort 29.8%, comparative cohort 16.7%, randomized trial 25.0%; TKA: single cohort 25.0%, comparative cohort 31.4%, randomized trial 48.6%). Furthermore, most devices were evaluated in only one study (55.3% TKA implants, 61.1% UKA implants). CONCLUSIONS: Patients, physicians, hospitals and payers rely on poor-quality evidence to support decisions about knee implants. Further research is needed to explore how decisions about the use of devices are currently made, and how the evidence base for device safety and effectiveness can be strengthened.

ReCAP: Comparison of Independent Error Checks for Oral Versus Intravenous Chemotherapy.

PURPOSE: Intravenous (IV) chemotherapy is routinely delivered to patients in hospital settings, where safeguards such as independent checks and guidelines govern their administration. In contrast, oral chemotherapy, which is typically ordered in a cancer center but dispensed and administered in the community and home, respectively, is subject to fewer controls. Research in the United States has found that few safeguards in routine use for IV chemotherapy have been adopted for oral chemotherapy; however, less is known about the Canadian context. The objective of this study was to determine whether similar safeguards, in the form of independent checks, existed to identify potential errors related to both formulations. METHODS: Human factors specialists conducted observations and interviews in cancer center clinics, a cancer center pharmacy, and four community pharmacies across Nova Scotia. Processes were analyzed to determine if an independent check was performed, which qualified provider completed the check, and at what point of the process the check occurred. RESULTS: A total of 57 systematic checks were identified for IV chemotherapy, whereas only six systematic checks were identified for oral chemotherapy. Community pharmacists were the only qualified professionals involved in independent systematic checking of oral chemotherapy, which occurred during ordering and dispensing. CONCLUSION: There is an enormous opportunity for pharmacists and other qualified professionals to take on an expanded role in improving patient safety for oral chemotherapy. Greater involvement of pharmacists, in both the clinic environment and the community, would facilitate increased systematic checking, which could improve patient safety related to oral chemotherapy.

The relationship between interruption content and interrupted task severity in intensive care nursing: an observational study.

BACKGROUND: In a previous study, we observed that the majority of interruptions experienced by nurses in a cardiovascular intensive care unit (CVICU) carried information directly related to their patient or other aspects of work affecting other patients or indirectly affecting their patient. Further, the proportion of interruptions with personal content was significantly higher during low-severity (in case of an error as defined by nurses) tasks compared to medium- and high-severity tasks suggesting that other personnel may have evaluated the criticality of the nurses' tasks before interrupting. However, this earlier study only collected data when an interruption happened and thus could not investigate interruption rate as a function of primary task type and severity while controlling for primary task duration as an exposure variable. OBJECTIVES: We addressed this methodological limitation in a second observational study that was conducted to further study interruptions and also to evaluate an interruption mitigation tool. The data from the baseline condition (i.e., no tool) is analyzed in this paper to validate the results of our previous study and to report interruption rates observed during tasks of varying severities (low, medium, high), with a particular focus on comparing different interruption contents. DESIGN AND SETTING: The study was conducted in a 24-bed closed CVICU at a Canadian hospital, during day shifts. PARTICIPANTS: The baseline condition involved thirteen nurses. METHODS: Over a 3-week period, three researchers observed these nurses 46-120 min each, with an average of 89 min. Data were collected in real time, using a tablet computer and software designed for this purpose. The rate of interruptions with different content was compared across varying task severity levels as defined by CVICU nurses. RESULTS: Nurses spent about 50% of their time conducting medium-severity tasks (e.g., documentation), 35% conducting high-severity tasks (e.g., procedure), and 14% conducting low-severity tasks (e.g., general care). The rate of interruptions with personal content observed during low-severity tasks was 1.97 (95% confidence interval, CI: 1.04, 3.74) and 3.23 (95% CI: 1.51, 6.89) times the rate of interruptions with personal content observed during high- and medium-severity tasks, respectively. CONCLUSIONS: Interrupters might have evaluated task severity before interrupting. Increasing the transparency of the nature and severity of the task being performed may help others further modulate when and how they interrupt a nurse. Overall, rather than try to eliminate all interruptions, mitigation strategies should consider the relevance of interruptions to a task or patient as well as their urgency.

Mitigating nonurgent interruptions during high-severity intensive care unit tasks using a task-severity awareness tool: A quasi-controlled observational study.

PURPOSE: In a previous study of interruptions to intensive care unit (ICU) nurses, we found that other personnel tend to regulate their interruptions based on nurses' tasks. However, nurses' tasks are not always immediately visible to an interrupter. This article evaluates a task-severity awareness tool (TAT) designed for nurses to inform others when they are performing high-severity tasks. When a nurse engages the tool within an ICU room, a "do not disturb please!" message is displayed outside the room. METHODS: Task-severity awareness tool was installed in a cardiovascular ICU room at a Canadian hospital. Fifteen nurses assigned to the TAT room and 13 nurses assigned to 11 other rooms were observed, approximately 2 hours each, over a 3-week period. Data were collected in real time, using a tablet computer. RESULTS: Interruption rate during high-severity tasks in the TAT room was significantly lower than in other rooms; interruptions with personal content were entirely mitigated during high-severity tasks. Furthermore, interruptions from nurses and medical doctors were also entirely mitigated during high-severity tasks but happened more frequently during non-high-severity tasks compared with rooms with no TAT. CONCLUSIONS: Task-severity awareness tool proved to be effective in mitigating unnecessary interruptions to critical tasks. Future research should assess its long-term effectiveness.

Interruptions experienced by cardiovascular intensive care unit nurses: an observational study.

PURPOSE: Intensive care unit (ICU) nurses get interrupted frequently. Although interruptions take cognitive resources from a primary task and may hinder performance, they may also convey critical information. Effective management of interruptions in ICUs requires the understanding of interruption characteristics, the context in which interruption happens, and interruption content. METHODS: An observational study was conducted in a cardiovascular ICU at a Canadian teaching hospital. Four observers (1 PhD and 3 undergraduate students) trained in human factors research observed 40 nurses, approximately 1 hour each, over a 3-week period. Data were recorded by the observers in real time, using touchscreen tablet PCs and special software designed for this purpose. RESULTS: Although approximately half of the interruptions (~51%) happened during high-severity tasks, more than half of these interruptions, which happened during high-severity tasks, conveyed either work- or patient-related information. Furthermore, the rate of interruptions with personal content was significantly higher during low-severity tasks compared with medium- and high-severity tasks. CONCLUSIONS: Mitigation strategies other than blocking should also be explored. In addition, interrupters might have evaluated primary task severity before interrupting. Therefore, making task severity more transparent may help others modulate when and how they interrupt a nurse.

Intravenous chemotherapy preparation errors: patient safety risks identified in a pan-Canadian exploratory study.

BACKGROUND: This exploratory study was launched following a critical chemotherapy medication incident to thoroughly and proactively examine the current processes for ordering, preparing, labeling, verifying, administering, and documenting ambulatory intravenous chemotherapy in Canada, and to identify factors that may contribute to preventable adverse drug events. METHODS: Field observations in six Canadian cancer centers to identify end-to-end processes in clinic, pharmacy, and treatment areas; analysis of processes to identify risks. RESULTS: Three types of previously locally unrecognized potential chemotherapy preparation errors in Canadian oncology pharmacies were uncovered, all of which are undetectable if they occur. Although the frequency of these errors is unknown, their impact is potentially catastrophic. INTERPRETATION: Dispensing errors in high-risk intravenous preparation have been studied in the past, but it is unlikely that these studies have detected these errors because of the inherent limitations of the detection methods used. Research on preparation errors using more sensitive methods is therefore urgently needed to establish the extent to which pharmacy preparation practices may be error-prone, and to allow reliable evaluation of the impact of mitigation strategies. Widespread practice changes in Canadian oncology pharmacies are necessary, and are currently underway.

Multiple Intravenous Infusions Phase 2a: Ontario Survey.

BACKGROUND: Research conducted in earlier phases of this study prospectively identified a number of concerns related to the safe administration of multiple intravenous (IV) infusions in Ontario hospitals. OBJECTIVE: To investigate the potential prevalence of practices or policies that may contribute to the patient safety risks identified in Phase 1b of this study. DATA SOURCES AND REVIEW METHODS: Sixty-four survey responses were analyzed from clinical units where multiple IV infusions may occur (e.g., adult intensive care units). Survey questions were organized according to the topics identified in Phase 1b as potential contributors to patient harm (e.g., labelling practices, patient transfer practices, secondary infusion policies). RESULTS: Survey results indicated suboptimal practices and policies in some clinical units, and variability in a number of infusion practices. Key areas of concern included the following: use of primary IV tubing without back check valves when administering secondary infusions, administration of secondary infusions with/as high-alert continuous IV medications, potential confusion about how IV tubing should be labelled to reflect replacement date and time, interruptions to IV therapy due to IV pump and/or tubing changes when patients are transferred between clinical units, coadministration of continuous or intermittent infusions on central venous pressure monitoring ports, variability in respondents' awareness of the infusion pump's bolus capabilities. LIMITATIONS: Due to the limited sample size, survey responses may not be representative of infusion practices across Ontario. Answers to some questions indicated that the intent of the questions might have been misunderstood. Due to a design error, 1 question about bolus administration methods was not shown to as many respondents as appropriate. CONCLUSIONS: The Ontario survey revealed variability in IV infusion practice across the province and potential opportunities to improve safety.

Multiple Intravenous Infusions Phase 2b: Laboratory Study.

BACKGROUND: Administering multiple intravenous (IV) infusions to a single patient via infusion pump occurs routinely in health care, but there has been little empirical research examining the risks associated with this practice or ways to mitigate those risks. OBJECTIVES: To identify the risks associated with multiple IV infusions and assess the impact of interventions on nurses' ability to safely administer them. DATA SOURCES AND REVIEW METHODS: Forty nurses completed infusion-related tasks in a simulated adult intensive care unit, with and without interventions (i.e., repeated-measures design). RESULTS: Errors were observed in completing common tasks associated with the administration of multiple IV infusions, including the following (all values from baseline, which was current practice): setting up and programming multiple primary continuous IV infusions (e.g., 11.7% programming errors)identifying IV infusions (e.g., 7.7% line-tracing errors)managing dead volume (e.g., 96.0% flush rate errors following IV syringe dose administration)setting up a secondary intermittent IV infusion (e.g., 11.3% secondary clamp errors)administering an IV pump bolus (e.g., 11.5% programming errors)Of 10 interventions tested, 6 (1 practice, 3 technology, and 2 educational) significantly decreased or even eliminated errors compared to baseline. LIMITATIONS: The simulation of an adult intensive care unit at 1 hospital limited the ability to generalize results. The study results were representative of nurses who received training in the interventions but had little experience using them. The longitudinal effects of the interventions were not studied. CONCLUSIONS: Administering and managing multiple IV infusions is a complex and risk-prone activity. However, when a patient requires multiple IV infusions, targeted interventions can reduce identified risks. A combination of standardized practice, technology improvements, and targeted education is required.

The effects of interruptions on oncologists' patient assessment and medication ordering practices.

Interruptions are causal factors in medication errors. Although researchers have assessed the nature and frequency of interruptions during medication administration, there has been little focus on understanding their effects during medication ordering. The goal of this research was to examine the nature, frequency, and impact of interruptions on oncologists' ordering practices. Direct observations were conducted at a Canadian cancer treatment facility to (1) document the nature, frequency, and timing of interruptions during medication ordering, and (2) quantify the use of coping mechanisms by oncologists. On average, oncologists were interrupted 17 % of their time, and were frequently interrupted during safety-critical stages of medication ordering. When confronted with interruptions, oncologists engaged/multitasked more often than resorting to deferring/blocking. While some interruptions are necessary forms of communication, efforts must be made to reduce unnecessary interruptions during safety-critical tasks, and to develop interventions that increase oncologists' resiliency to inevitable interruptions.

Implementation and optimization of smart infusion systems: are we reaping the safety benefits?

To address the high incidence of infusion errors, manufacturers have replaced the development of standard infusion pumps with smart pump systems. The implementation and ongoing optimization processes for smart pumps are more complex, as they require larger coordinated efforts with stakeholders throughout the medication process. If improper implementation/optimization processes are followed, hospitals invest in this technology while extracting minimal benefit. We assessed the processes hospitals employed when migrating from standard to smart infusion systems, and the extent to which they leveraged their investments from both a systems and resource perspective. Twenty-nine hospitals in Ontario, Canada, were surveyed that had either implemented smart pump systems or were in the process of implementing, representing a response rate of 69%. Results demonstrated that hospitals purchased smart pumps for reasons other than safety, did not involve a multidisciplinary team during implementation, made little effort to standardize drug concentrations or develop drug libraries and dosing limits, seldom monitored how nurses use the pumps, and failed to ensure wireless connectivity to upgrade protocols and download use data. Consequently, they are failing to realize the safety benefits these systems can provide.

Optimizing the design of preprinted orders for ambulatory chemotherapy: combining oncology, human factors, and graphic design.

PURPOSE: To establish a set of guidelines for developing ambulatory chemotherapy preprinted orders. METHODS: Multiple methods were used to develop the preprinted order guidelines. These included (A) a comprehensive literature review and an environmental scan; (B) analyses of field study observations and incident reports; (C) critical review of evidence from the literature and the field study observation analyses; (D) review of the draft guidelines by a clinical advisory group; and (E) collaboration with graphic designers to develop sample preprinted orders, refine the design guidelines, and format the resulting content. RESULTS: The Guidelines for Developing Ambulatory Chemotherapy Preprinted Orders, which consist of guidance on the design process, content, and graphic design elements of ambulatory chemotherapy preprinted orders, have been established. CONCLUSION: Health care is a safety critical, dynamic, and complex sociotechnical system. Identifying safety risks in such a system and effectively addressing them often require the expertise of multiple disciplines. This study illustrates how human factors professionals, clinicians, and designers can leverage each other's expertise to uncover commonly overlooked patient safety hazards and to provide health care professionals with innovative, practical, and user-centered tools to minimize those hazards.

Order sets in health care: a systematic review of their effects.

OBJECTIVES: Order sets are widely used in hospitals to enter diagnosis and treatment orders. To determine the effectiveness of order sets in improving guideline adherence, treatment outcomes, processes of care, efficiency, and cost, we conducted a systematic review of the literature. METHODS: A comprehensive literature search was performed in various databases for studies published between January 1, 1990, and April 18, 2009. A total of eighteen studies met inclusion criteria. No randomized controlled trials were found. RESULTS: Outcomes of the included studies were summarized qualitatively due to variations in study population, intervention type, and outcome measures. There were no important inconsistencies between the results reported by studies involving different types of order sets. While the studies generally suggested positive outcomes, they were typically of low quality, with simple before-after designs and other methodological limitations. CONCLUSIONS: The benefits of order sets remain eminently plausible, but given the paucity of high quality evidence, further investigations to formally evaluate the effectiveness of order sets would be highly valuable.

Effect of home blood pressure telemonitoring with self-care support on uncontrolled systolic hypertension in diabetics.

Lowering blood pressure reduces cardiovascular risk, yet hypertension is poorly controlled in diabetic patients. In a pilot study we demonstrated that a home blood pressure telemonitoring system, which provided self-care messages on the smartphone of hypertensive diabetic patients immediately after each reading, improved blood pressure control. Messages were based on care paths defined by running averages of transmitted readings. The present study tests the system's effectiveness in a randomized, controlled trial in diabetic patients with uncontrolled systolic hypertension. Of 244 subjects screened for eligibility, 110 (45%) were randomly allocated to the intervention (n = 55) or control (n = 55) group, and 105 (95.5%) completed the 1-year outcome visit. In the intention-to-treat analysis, mean daytime ambulatory systolic blood pressure, the primary end point, decreased significantly only in the intervention group by 9.1 ± 15.6 mmHg (SD; P < 0.0001), and the mean between-group difference was 7.1 ± 2.3 mmHg (SE; P < 0.005). Furthermore, 51% of intervention subjects achieved the guideline recommended target of <130/80 mmHg compared with 31% of control subjects (P < 0.05). These improvements were obtained without the use of more or different antihypertensive medications or additional clinic visits to physicians. Providing self-care support did not affect anxiety but worsened depression on the Hospital Anxiety and Depression Scale (baseline, 4.1 ± 3.76; exit, 5.2 ± 4.30; P = 0.014). This study demonstrated that home blood pressure telemonitoring combined with automated self-care support reduced the blood pressure of diabetic patients with uncontrolled systolic hypertension and improved hypertension control. Home blood pressure monitoring alone had no effect on blood pressure. Promoting patient self-care may have negative psychological effects.