Information and communication priorities of patients and healthcare professionals in shared decision making regarding adjuvant systemic breast cancer treatment: A survey study.

PURPOSE: To assess information and communication priorities of patients and healthcare professionals in Shared Decision Making about adjuvant systemic treatment of primary breast cancer and identify key decision-relevant information accordingly. METHODS: Patients (N = 122) and professionals working with breast cancer patients (N = 118), of whom 38 were nurse practitioners and 32 nurses, were recruited using convenience sampling, and surveyed about information/communication aspects key to decision-making, using ranking assignments. We further posed a simple open question, questions about receiving population-based statistics versus personalized statistics concerning treatment outcomes, and their attitude and experience concerning Shared Decision Making. Data were analyzed using descriptive analysis and a qualitative analysis. RESULTS: Both patients and professionals prioritized information about treatment outcomes (i.e., survival, recurrence) as key decision-relevant information for patients. Patients prioritized information about relatively severe treatment side-effects and late effects (e.g., blood clot, stroke), whilst professionals prioritized information about effects that occur relatively often (e.g., hair loss, fatigue). Patients specifically wanted to know if the benefit of treatment is worth the negative impact. Both groups prioritized personalized statistics over population-based statistics. CONCLUSIONS: Some differences between patients and professionals were found in information and communication priorities, specifically related to the different side-effects. It seems worthwhile to precisely address these side-effects in Shared Decision Making concerning adjuvant systemic treatment. Furthermore, it seems important to deliberate together on the question if expected benefit of treatment is worth the potential negative impact for the individual patient.

Behavioral sciences applied to acute care teams: a research agenda for the years ahead by a European research network.

BACKGROUND: Multi-disciplinary behavioral research on acute care teams has focused on understanding how teams work and on identifying behaviors characteristic of efficient and effective team performance. We aimed to define important knowledge gaps and establish a research agenda for the years ahead of prioritized research questions in this field of applied health research. METHODS: In the first step, high-priority research questions were generated by a small highly specialized group of 29 experts in the field, recruited from the multinational and multidisciplinary "Behavioral Sciences applied to Acute care teams and Surgery (BSAS)" research network - a cross-European, interdisciplinary network of researchers from social sciences as well as from the medical field committed to understanding the role of behavioral sciences in the context of acute care teams. A consolidated list of 59 research questions was established. In the second step, 19 experts attending the 2020 BSAS annual conference quantitatively rated the importance of each research question based on four criteria - usefulness, answerability, effectiveness, and translation into practice. In the third step, during half a day of the BSAS conference, the same group of 19 experts discussed the prioritization of the research questions in three online focus group meetings and established recommendations. RESULTS: Research priorities identified were categorized into six topics: (1) interventions to improve team process; (2) dealing with and implementing new technologies; (3) understanding and measuring team processes; (4) organizational aspects impacting teamwork; (5) training and health professions education; and (6) organizational and patient safety culture in the healthcare domain. Experts rated the first three topics as particularly relevant in terms of research priorities; the focus groups identified specific research needs within each topic. CONCLUSIONS: Based on research priorities within the BSAS community and the broader field of applied health sciences identified through this work, we advocate for the prioritization for funding in these areas.

Evaluation of an infection control link nurse program: an analysis using the RE-AIM framework.

BACKGROUND: Important elements of programs that train and support infection control link nurses (ICLN) are the engagement of stakeholders, support from hospital and ward management and a structure for iterative improvement. The effects of programs, that combine all these elements, are unknown. We evaluated such a comprehensive program to explore its impact on link nurses and infection prevention practices and routines. METHODS: We used the RE-AIM framework, a robust, evidence-based framework within the field of Implementation Science, to evaluate the impact of our ICLN training and support program. We used a mixed methods approach and organized the outcomes along its five dimensions: Reach, Effectiveness, Adoption, Implementation and Maintenance. RESULTS: Between 2014 and 2018, on average 91% of the inpatient wards and 58% of the outpatient clinics participated in the program (Reach) and impacted guideline adherence in inpatient wards. Link nurses felt engaged and empowered, and perceived their contribution to these results as pivotal. Ward managers confirmed the value of ICLN to help with implementing IPC practices (Effectiveness). The program was adopted both at the hospital and at the ward level (Adoption). Based on ongoing evaluations, the program was adapted by refining education, training and support strategies with emphasis on ward specific aspects (Implementation). The ICLN program was described as a key component of the infection prevention policy to sustain its effects (Maintenance). CONCLUSIONS: Our infection control link nurse program helped ICLN to improve infection prevention practices, especially in inpatient wards. The key to these improvements lay within the adaptability of our link nurse program. The adjustments to the program led to a shift of focus from hospital goals to goals tailored to the ward level. It allowed us to tailor activities to align them with the needs specific to each ward.

Role perception of infection control link nurses; a multi-centre qualitative study.

Background: Infection control link nurses (ICLN) disseminate knowledge on infection prevention topics to their peers. Little is known about how they succeed and thereby contribute to infection prevention in daily practise. Aim: To explore the experiences of infection control link nurses regarding their role in acute care hospitals and identify perceived facilitators and best practices. Methods: We conducted a qualitative study with semi-structured individual and focus group interviews with ICLN. The effect of COVID-19 on the ICLN role was added as a topic in focus group interviews during the pandemic. Results: Twenty-six ICLN working in acute care hospitals were interviewed. ICLN perceived their role as to identify, monitor, facilitate and inform their colleagues on infection prevention topics related to their ward. Their experiences vary from feeling challenged and wonder how to get started, to feeling confident and taking initiatives that lead to ward-based improvements. When inspired by each other and supported by infection control practitioners or managers, ICLN feel empowered to initiate more activities to improve practice. During the COVID-19 pandemic, ICLN felt their responsibilities were magnified. When transferred to another ward, the focus on the ICLN role seemed dispersed. Discussion: Empowered ICLN adjust and operationalize infection prevention policies to fit the conditions of their specific wards and provide practical instructions and feedback to their peers which enable better compliance to infection prevention policies. Support and inspiration from other ICLN, infection control practitioners and management contribute to this empowerment and consequently to taking impactful initiatives to improve practice.

A pragmatic approach for implementation of value-based healthcare in Amsterdam UMC, the Netherlands.

BACKGROUND: The emphasis on implementation of value-based healthcare (VBHC) has increased in the Dutch healthcare system. Yet, the translation of the theoretical principles of VBHC towards actual implementation in daily practice has been rarely described. Our aim is to present a pragmatic step-by-step approach for VBHC implementation, developed and applied in Amsterdam UMC, to share our key elements. The approach may inspire others and can be used as a template for implementing VBHC principles in other hospitals. METHODS: The local approach is developed in a major academic hospital in the Netherlands, based at two locations with 15,000 employees in total. Experience-based co-design is used, building on our learning experiences from implementing VBHC for 14 specific patient groups. The described steps and activities devolved from iterative and participative co-design sessions with various experienced stakeholders involved in the implementation of one or more VBHC pathways. RESULTS: The approach includes five phases; preparation, design (team introduction, outcome selection, action agenda), building (outcome set integration in daily practice), implementation (training, outcome registration and implementation) and the continuous improvement cycle. We described two cases for illustration of the approach; the Cleft Lip and Palate and the Chronic Kidney Disease patient groups. For a good start, involvement of a clinical leader as driving force, ensuring participation of patient representatives and sufficient resources are needed. CONCLUSION: We have experienced that several defining features of the development and implementation of this approach may have contributed to its completeness and applicability. Key elements for success have been organisational readiness and clinical leadership. In conclusion, the approach has provided a first step towards VBHC in our hospital. Further research is needed for evaluation of its effectiveness including impact on value for patients.

The Incidence and Nature of Adverse Medical Device Events in Dutch Hospitals: A Retrospective Patient Record Review Study.

OBJECTIVES: Despite widespread use of medical devices and their increasing complexity, their contribution to unintended injury caused by healthcare (adverse events, AEs) remains relatively understudied. The aim of this study was to gain insight in the incidence and types of AEs involving medical devices (AMDEs). METHODS: Data from two patient record studies for the identification of AEs were used. Identification of AMDEs was part of these studies. Patient records of 6894 admissions of a random sample of 20 hospitals in 2011/2012 and 19 hospitals in 2015/2016 were reviewed for AMDEs by trained nurses and physicians. RESULTS: In 98.7% of the admissions, a medical device was used. Adverse events involving medical devices were present in 2.8% of the admissions, with 24% of the AMDEs being potentially preventable. Of all AEs, in 40%, medical devices were involved. Of all potentially preventable AEs, in 44%, medical devices were involved. Implants were most often involved in potentially preventable AMDEs. CONCLUSIONS: Medical devices are substantially involved in potentially preventable AEs in hospitals. Research into AMDEs is of great importance because of the increasing use and complexity of medical devices. Based on patient records, most improvements could be made for placement of implants and prevention of infections related to medical devices. Safety and safe use of medical devices should be a subject of attention and further research.

Improving the Competency of Nurses.

To decrease infusion pump administration errors, time-consuming training is often initiated. The aims of this study were twofold: to develop minimum competency requirements for programming and operation of infusion pumps and to develop and validate a test for nurses based on those requirements. The test was completed by 226 nurses between May and December 2017. This study demonstrates that testing is a promising method to assess the competency of nurses in using medical devices. Moreover, test acceptability among nurses is high. Using competency requirements to develop a test offers the potential to tailor training needs and reduce training time.

The use of PROMs and shared decision-making in medical encounters with patients: An opportunity to deliver value-based health care to patients.

BACKGROUND: The recent emphasis on value-based health care (VBHC) is thought to provide new opportunities for shared decision-making (SDM) in the Netherlands, especially when using patient-reported outcome measures (PROMs) in routine medical encounters. It is still largely unclear about how PROMs could be linked to SDM and what we expect from clinicians in this respect. AIM: To describe approaches and lessons learned in the fields of SDM and VBHC implementation that converge in using PROMs in medical encounters. APPROACH: Based on input from three Dutch forerunner case examples and available evidence about SDM and VBHC, we describe barriers and facilitators regarding the use of PROMs and SDM in the medical encounter. Barriers and facilitators were structured according to a conversational model that included monitoring and managing, team talk, option talk, choice talk, and decision talk. Key lessons learned and recommendations were synthesized. RESULTS: The use of individual, N = 1 PROMs scores in the medical encounter has been largely achieved in the forerunner projects. Conversation on monitoring and managing is relatively well implemented, and option talk to some extent, unlike team talk, and decision talk. Aggregated PROMs information describing outcomes of treatment options seemed to be scarcely used. Experienced barriers largely corresponded to what is known from the literature, eg, perceived lack of time and lack of tools summarizing the options. Some concerns were identified about increasing health care consumption as a result of using PROMs and SDM in the medical encounter. CONCLUSION: Successful implementation of SDM within VBHC initiatives may not be self-evident, even though individual, N = 1 PROMs scores are being used in the medical encounter. Education and staff resources on meso and macro levels may facilitate the more time-consuming SDM aspects. It seems fruitful to especially target team talk and choice talk in redesigning clinical pathways.

How reliable is perioperative anticoagulant management? Determining guideline compliance and practice variation by a retrospective patient record review.

OBJECTIVES: Surgery in patients on anticoagulants requires careful monitoring and risk assessment to prevent harm. Required interruptions of anticoagulants and deciding whether to use bridging anticoagulation add further complexity. This process, known as perioperative anticoagulant management (PAM), is optimised by using guidelines. Optimal PAM prevents thromboembolic and bleeding complications. The purpose of this study was to assess the reliability of PAM practice in Dutch hospitals. Additionally, the variations between hospitals and different bridging dosages were studied. DESIGN: A multicentre retrospective patient record review. SETTING AND PARTICIPANTS: Records from 268 patients using vitamin-K antagonist (VKA) anticoagulants who underwent surgery in a representative random sample of 13 Dutch hospitals were reviewed, 259 were analysed. PRIMARY AND SECONDARY OUTCOME MEASURES: Our primary outcome measure was the reliability of PAM expressed as the percentage of patients receiving guideline compliant care. Seven PAM steps were included. Secondary outcome measures included different bridging dosages used and an analysis of practice variation on the hospital level. RESULTS: Preoperative compliance was lowest for timely VKA interruptions: 58.8% (95% CI 50.0% to 67.7%) and highest for timely preoperative assessments: 81% (95% CI 75.0% to 86.5%). Postoperative compliance was lowest for timely VKA restarts: 39.9% (95% CI 33.1% to 46.7%) and highest for the decision to apply bridging: 68.5% (95% CI 62.3% to 74.8%). Variation in compliance between hospitals was present for the timely preoperative assessment (range 41%-100%), international normalised ratio testing (range 21%-94%) and postoperative bridging (range 20%-88%). Subtherapeutic bridging was used in 50.5% of patients and increased with patients' weight. CONCLUSIONS: Unsatisfying compliance for most PAM steps, reflect suboptimal reliability of PAM. Furthermore, the hospital performance varied. This increases the risk for adverse events, warranting quality improvement. The development of process measures can help but will be complicated by the availability of a strong supporting evidence base and integrated care delivery regarding PAM.

Occurrence of Antithrombotic Related Adverse Events in Hospitalized Patients: Incidence and Clinical Context between 2008 and 2016.

Antithrombotic drugs are consistently involved in medication-related adverse events (MRAEs) in hospitalized patients. We aimed to estimate the antithrombotic-related adverse event (ARAE) incidence between 2008 and 2016 and analyse their clinical context in hospitalized patients in The Netherlands. A post-hoc analysis of three national studies, aimed at adverse event (AE) identification, was performed. Previously identified AEs were screened for antithrombotic involvement. Crude and multi-level, case-mix adjusted ARAE and MRAE incidences were calculated. Various contextual ARAE characteristics were analysed. ARAE incidence between 2008 and 2016 decreased significantly in in-hospital deceased patients from 1.20% (95% confidence interval (CI): 0.63-2.27%) in 2008 to 0.54% (95% CI: 0.27-1.11%) in 2015/2016 (p = 0.02). In discharged patients ARAE incidence remained stable. By comparison, overall MRAE incidence remained stable for both deceased and discharged patients. Most ARAEs involved Vitamin-K antagonists (VKAs). Preventable ARAEs occurred more during weekends and with increasing multidisciplinary involvement. Antiplatelet and combined antithrombotic use seemed to be increasingly involved in ARAEs over time. ARAE incidence declined by 55% in deceased patients between 2008 and 2016. Opportunities for improving antithrombotic safety should target INR monitoring and care delivery aspects such as multidisciplinary involvement and weekend care. Future ARAE monitoring for the involvement of antiplatelet, combined antithrombotic and direct oral anticoagulant (DOAC) use is recommended.

How do studies assess the preventability of readmissions? A systematic review with narrative synthesis.

BACKGROUND: A large number of articles examined the preventability rate of readmissions, but comparison and interpretability of these preventability rates is complicated due to the large heterogeneity of methods that were used. To compare (the implications of) the different methods used to assess the preventability of readmissions by means of medical record review. METHODS: A literature search was conducted in PUBMED and EMBASE using "readmission" and "avoidability" or "preventability" as key terms. A consensus-based narrative data synthesis was performed to compare and discuss the different methods. RESULTS: Abstracts of 2504 unique citations were screened resulting in 48 full text articles which were included in the final analysis. Synthesis led to the identification of a set of important variables on which the studies differed considerably (type of readmissions, sources of information, definition of preventability, cause classification and reviewer process). In 69% of the studies the cause classification and preventability assessment were integrated; meaning specific causes were predefined as preventable or not preventable. The reviewers were most often medical specialist (67%), and 27% of the studies added interview as a source of information. CONCLUSION: A consensus-based standardised approach to assess preventability of readmission is warranted to reduce the unwanted bias in preventability rates. Patient-related and integrated care related factors are potentially underreported in readmission studies.

Using PROMs during routine medical consultations: The perspectives of people with Parkinson's disease and their health professionals.

BACKGROUND: The use of patient-reported outcomes measures (PROMs), such as quality of life or symptoms like pain or fatigue, is increasingly embraced within patient-centred care and shared decision making. OBJECTIVES: To investigate: (a) how patients and health professionals think about using PROMs during routine medical consultations; (b) for which purpose(s), patients and health professionals want to use PROMs during those consultations; and (c) how patients interpret PROMs information presented in various formats. People with Parkinson's disease and their health professionals served as case example. METHODS: We performed semi-structured interviews with patients (N = 13) and professionals (N = 7 neurologists; N = 7 physiotherapists). We also used a survey in which patients (N = 115) were shown six figures displaying different information types. Presentation formats of this information varied (line/bar graphs). Interpretation by patients, perceived usefulness of information, attitude towards using information during routine medical consultations and (hypothetical) decisions were assessed. FINDINGS: Patients and professionals were generally positive about using PROMs during medical consultations. Professionals stressed the opportunity to monitor changes in individual PROMs over time. Patients were primarily positive about aggregated PROMs to make treatment decisions. This information was also most often interpreted correctly, especially when presented through a line graph (90.1% correct). Professionals thought patients should take the initiative in discussing PROMs, whereas patients thought professionals should do so. CONCLUSION/DISCUSSION: When used in routine medical consultations, PROMs seem to have potential to support shared decision making and facilitate patient-professional communication. However, training seems needed for both patients and professionals to facilitate actual discussion and proper interpretation.

Cost-effectiveness of a clinical medication review in vulnerable older patients at hospital discharge, a randomized controlled trial.

Background Drug-related problems (DRP) following hospital discharge may cause morbidity, mortality and hospital re-admissions. It is unclear whether a clinical medication review (CMR) and counseling at discharge is a cost-effective method to reduce DRP. Objective To assess the effect of a CMR on health care utilization and to investigate whether CMR is a cost-effective method to reduce DRP in older polypharmacy patients discharged from hospital. Setting 24 community pharmacies in the Netherlands. Method A cluster-randomized controlled trial with an economic evaluation. Community pharmacies were randomized to those providing a CMR, counseling and follow-up at discharge and those providing usual care. Main outcome measures Change in the number of DRP after 1 year of follow-up and costs of health care utilization during follow-up. In 216 patients the use of health care was prospectively assessed. Missing data on effects and costs were imputed using multiple imputation techniques. Bootstrapping techniques were used to estimate the uncertainty around the differences in costs and incremental cost-effectiveness ratios. Results CMR resulted in a small reduction of DRP. The proportion of patients readmitted to the hospital during 6 months of follow-up was significantly higher in the intervention group than in the control group (46.4 vs. 20.9%; p < 0.05). Health care costs were higher in the intervention group, although not statistically significant. The costs of reducing one DRP by a CMR amounted to €8270. Conclusion A CMR in vulnerable older patients at hospital discharge led to a small reduction in DRP. Because of a significantly higher use of health care and higher number of re-hospitalisations post CMR, the present study data indicate that performing the intervention in this patient population is not cost-effective.

Impact of Electronic versus Paper-Based Recording before EHR Implementation on Health Care Professionals' Perceptions of EHR Use, Data Quality, and Data Reuse.

BACKGROUND: The implementation of an electronic health record (EHR) with structured and standardized recording of patient data can improve data quality and reusability. Whether and how users perceive these advantages may depend on the preimplementation situation. OBJECTIVE: To determine whether the influence of implementing a structured and standardized EHR on perceived EHR use, data quality, and data reuse differed for users working with paper-based records versus a legacy EHR before implementation. METHODS: We used an electronic questionnaire to measure users' perception before implementation (2014), expected change, and perceived change after implementation (2016) on three themes. We included all health care professionals in two university hospitals in the Netherlands. Before jointly implementing the same structured and standardized EHR, one hospital used paper-based records and the other a legacy EHR. We compared perceptions before and after implementation for both centers. Additionally, we compared expected benefit with perceived benefit. RESULTS: We received 7,611 responses (4,537 before and 3,074 after implementation) of which 5,707 (75%) were from professionals reading and recording patient data. A total of 975 (13%) professionals responded to both before and after implementation questionnaires. In the formerly paper-based center staff perceived improvement in all themes after implementation. The legacy EHR center experienced deterioration of perceived EHR use and data reuse, and only one improvement in EHR use. In both centers, for half of the aspects at least 45% of responders experienced results worse than expected preimplementation. CONCLUSION: Our results indicate that the preimplementation recording practice impacts the perceived effect of the implementation of a structured and standardized EHR. For almost half of the respondents the new EHR did not meet their expectations. Especially legacy EHR centers need to investigate the expectations as these might be different and less clear cut than those in paper-based centers. These expectations need to be addressed appropriately to achieve a successful implementation.

Infection control link nurses in acute care hospitals: a scoping review.

Background: Involving link nurses in infection prevention and control is a strategy to improve clinical practice that has been implemented in hospitals worldwide. However, little is known about the use, the range and benefits of this strategy. We aimed to identify key concepts of infection control link nurses (ICLN) and ICLN programs, to evaluate the effect of such programs, and to identify gaps in the evidence base. Methods: In a scoping review, we searched PubMed, CINAHL, Google and Google Scholar for manuscripts on ICLN in acute care hospitals. We included research- and opinion-based papers, abstracts, reports and guidelines. Results: We included 29 publications and identified three key concepts: the profile of ICLN, strategies to support ICLN, and the implementation of ICLN programs. The majority of included studies delineates the ICLN profile with accompanying roles, tasks and strategies to support ICLN, without a thorough evaluation of the implementation process or effects. Few studies report on the effect of ICLN programs in terms of patient outcomes or guideline adherence, with positive short term effects. Conclusion: This scoping review reveals a lack of robust evidence on the effectiveness of ICLN programs. Current best practice for an ICLN program includes a clear description of the ICLN profile, education on infection prevention topics as well as training in implementation skills, and support from the management at the ward and hospital level. Future research is needed to evaluate the effects of ICLN on clinical practice and to further develop ICLN programs for maximal impact.

Interruptions during intravenous medication administration: A multicentre observational study.

AIMS: The aim of this study was to determine the frequency and cause of interruptions during intravenous medication administration, which factors are associated with interruptions and to what extent interruptions influence protocol compliance. BACKGROUND: Hospital nurses are frequently interrupted during medication administration, which contributes to the occurrence of administration errors. Errors with intravenous medication are especially worrisome, given their immediate therapeutic effects. However, knowledge about the extent and type of interruptions during intravenous medication administration is limited. DESIGN: Multicentre observational study. METHODS: Data were collected during two national evaluation studies (2011 - 2012 & 2015 - 2016). Nurses were directly observed during intravenous medication administration. An interruption was defined as a situation where a break during the administration was needed or where a nurse was distracted but could process without a break. Interruptions were categorized according to source and cause. Multilevel logistic regression analyses were conducted to assess the associations between explanatory variables and interruptions or complete protocol compliance. RESULTS: In total, 2,526 intravenous medication administration processes were observed. During 291 (12%) observations, nurses were interrupted 321 times. Most interruptions were externally initiated by other nurses (19%) or patients (19%). Less interruptions occurred during the evening (odds ratio: 0.23 [95% confidence interval: 0.08-0.62]). Do-not-disturb vests were worn by 61 (2%) nurses. No significant association was found between being interrupted and complete protocol compliance. CONCLUSION: An interruption occurred in every eight observed intravenous medication administration, mainly caused by other nurses or patients. One needs to consider critically which strategies effectively improve safety during the high-risk nursing-task of intravenous medication administration.

Development and validation of a model for the adoption of structured and standardised data recording among healthcare professionals.

BACKGROUND: Healthcare professionals provide care to patients and during that process, record large quantities of data in patient records. Data in an Electronic Health Record should ideally be recorded once and be reusable within the care process as well as for secondary purposes. A common approach to realise this is to let healthcare providers record data in a standardised and structured way at the point of care. Currently, it is not clear to what extent this structured and standardised recording has been adopted by healthcare professionals and what barriers to their adoption exist. Therefore, we developed and validated a multivariable model to capture the concepts underlying the adoption of structured and standardised recording among healthcare professionals. METHODS: Based on separate models from the literature we developed a new theoretical model describing the underlying concepts of the adoption of structured and standardised recording. Using a questionnaire built upon this model we gathered data to perform a summative validation of our model. Validation was done through partial least squares structural equation modelling (PLS-SEM). The quality of both levels defined in PLS-SEM analysis, i.e., the measurement model and the structural model, were assessed on performance measures defined in literature. RESULTS: The theoretical model we developed consists of 29 concepts related to information systems as well as organisational factors and personal beliefs. Based on these concepts, 59 statements with a 5 point Likert-scale (fully disagree to fully agree) were specified in the questionnaire. We received 3584 responses. The validation shows our model is supported to a large extent by the questionnaire data. Intention to record in a structured and standardised way emerged as a significant factor of reported behaviour (ß = 0.305, p < 0.001). This intention is influenced most by attitude (ß = 0.512, p < 0.001). CONCLUSIONS: This model can be used to measure the perceived level of adoption of structured and standardised recording among healthcare professionals and further improve knowledge on the barriers and facilitators of this adoption.

EXPLORING MEDICAL DEVICES: THE USE OF RISK ASSESSMENT TOOLS AND THEIR LINK WITH TRAINING IN HOSPITALS.

OBJECTIVES: The aim of this study was to explore the risk assessment tools and criteria used to assess the risk of medical devices in hospitals, and to explore the link between the risk of a medical device and how those risks impact or alter the training of staff. METHODS: Within a broader questionnaire on implementation of a national guideline, we collected quantitative data regarding the types of risk assessment tools used in hospitals and the training of healthcare staff. RESULTS: The response rate for the questionnaire was 81 percent; a total of sixty-five of eighty Dutch hospitals. All hospitals use a risk assessment tool and the biggest cluster (40 percent) use a tool developed internally. The criteria used to assess risk most often are: the function of the device (92 percent), the severity of adverse events (88 percent) and the frequency of use (77 percent). Forty-seven of fifty-six hospitals (84 percent) base their training on the risk associated with a medical device. For medium- and high-risk devices, the main method is practical training. As risk increases, the amount and type of training and examination increases. CONCLUSIONS: Dutch hospitals use a wide range of tools to assess the risk of medical devices. These tools are often based on the same criteria: the function of the device, the potential severity of adverse events, and the frequency of use. Furthermore, these tools are used to determine the amount and type of training required for staff. If the risk of a device is higher, then the training and examination is more extensive.

How Health Care Professionals Evaluate a Digital Intervention to Improve Medication Adherence: Qualitative Exploratory Study.

BACKGROUND: Medication nonadherence poses a serious and a hard-to-tackle problem for many chronic diseases. Electronic health (eHealth) apps that foster patient engagement and shared decision making (SDM) may be a novel approach to improve medication adherence. OBJECTIVE: The aim of this study was to investigate the perspective of health care professionals regarding a newly developed digital app aimed to improve medication adherence. Familial hypercholesterolemia (FH) was chosen as a case example. METHODS: A Web-based prototype of the eHealth app-MIK-was codesigned with patients and health care professionals. After user tests with patients, we performed semistructured interviews and user tests with 12 physicians from 6 different hospitals to examine how the functionalities offered by MIK could assist physicians in their consultation and how they could be integrated into daily clinical practice. Qualitative thematic analysis was used to identify themes that covered the physicians' evaluations. RESULTS: On the basis of the interview data, 3 themes were identified, which were (1) perceived impact on patient-physician collaboration; (2) perceived impact on the patient's understanding and self-management regarding medication adherence; and (3) perceived impact on clinical decisions and workflow. CONCLUSIONS: The eHealth app MIK seems to have the potential to improve the consultation between the patient and the physician in terms of collaboration and patient engagement. The impact of eHealth apps based on the concept of SDM for improving medication-taking behavior and clinical outcomes is yet to be evaluated. Insights will be useful for further development of eHealth apps aimed at improving self-management by means of patient engagement and SDM.