Perceptions and behavior of clinical researchers and research support staff regarding data FAIRification.

The FAIR Data Principles are being rapidly adopted by many research institutes and funders worldwide. This study aimed to assess the awareness and attitudes of clinical researchers and research support staff regarding data FAIRification. A questionnaire was distributed to researchers and support staff in six Dutch University Medical Centers and Electronic Data Capture platform users. 164 researchers and 21 support staff members completed the questionnaire. 62.8% of the researchers and 81.0% of the support staff are currently undertaking at least some effort to achieve any aspect of FAIR, 11.0% and 23.8%, respectively, address all aspects. Only 46.6% of the researchers add metadata to their datasets, 39.7% add metadata to data elements, and 35.9% deposit their data in a repository. 94.7% of the researchers are aware of the usefulness of their data being FAIR for others and 89.3% are, given the right resources and support, willing to FAIRify their data. Institutions and funders should, therefore, develop FAIRification training and tools and should (financially) support researchers and staff throughout the process.

FAIRification Efforts of Clinical Researchers: The Current State of Affairs.

The FAIR Principles are supported by various initiatives in the biomedical community. However, little is known about the knowledge and efforts of individual clinical researchers regarding data FAIRification. We distributed an online questionnaire to researchers from six Dutch University Medical Centers, as well as researchers using an Electronic Data Capture platform, to gain insight into their understanding of and experience with data FAIRification. 164 researchers completed the questionnaire. 64.0% of them had heard of the FAIR Principles. 62.8% of the researchers spent some or a lot of effort to achieve any aspect of FAIR and 11.0% addressed all aspects. Most researchers were unaware of the Principles' emphasis on both human- and machine-readability, as their FAIRification efforts were primarily focused on achieving human-readability (93.9%), rather than machine-readability (31.2%). In order to make machine-readable, FAIR data a reality, researchers require proper training, support, and tools to help them understand the importance of data FAIRification and guide them through the FAIRification process.

The de novo FAIRification process of a registry for vascular anomalies.

BACKGROUND: Patient data registries that are FAIR-Findable, Accessible, Interoperable, and Reusable for humans and computers-facilitate research across multiple resources. This is particularly relevant to rare diseases, where data often are scarce and scattered. Specific research questions can be asked across FAIR rare disease registries and other FAIR resources without physically combining the data. Further, FAIR implies well-defined, transparent access conditions, which supports making sensitive data as open as possible and as closed as necessary. RESULTS: We successfully developed and implemented a process of making a rare disease registry for vascular anomalies FAIR from its conception-de novo. Here, we describe the five phases of this process in detail: (i) pre-FAIRification, (ii) facilitating FAIRification, (iii) data collection, (iv) generating FAIR data in real-time, and (v) using FAIR data. This includes the creation of an electronic case report form and a semantic data model of the elements to be collected (in this case: the "Set of Common Data Elements for Rare Disease Registration" released by the European Commission), and the technical implementation of automatic, real-time data FAIRification in an Electronic Data Capture system. Further, we describe how we contribute to the four facets of FAIR, and how our FAIRification process can be reused by other registries. CONCLUSIONS: In conclusion, a detailed de novo FAIRification process of a registry for vascular anomalies is described. To a large extent, the process may be reused by other rare disease registries, and we envision this work to be a substantial contribution to an ecosystem of FAIR rare disease resources.

De-novo FAIRification via an Electronic Data Capture system by automated transformation of filled electronic Case Report Forms into machine-readable data.

INTRODUCTION: Existing methods to make data Findable, Accessible, Interoperable, and Reusable (FAIR) are usually carried out in a post hoc manner: after the research project is conducted and data are collected. De-novo FAIRification, on the other hand, incorporates the FAIRification steps in the process of a research project. In medical research, data is often collected and stored via electronic Case Report Forms (eCRFs) in Electronic Data Capture (EDC) systems. By implementing a de novo FAIRification process in such a system, the reusability and, thus, scalability of FAIRification across research projects can be greatly improved. In this study, we developed and implemented a novel method for de novo FAIRification via an EDC system. We evaluated our method by applying it to the Registry of Vascular Anomalies (VASCA). METHODS: Our EDC and research project independent method ensures that eCRF data entered into an EDC system can be transformed into machine-readable, FAIR data using a semantic data model (a canonical representation of the data, based on ontology concepts and semantic web standards) and mappings from the model to questions on the eCRF. The FAIRified data are stored in a triple store and can, together with associated metadata, be accessed and queried through a FAIR Data Point. The method was implemented in Castor EDC, an EDC system, through a data transformation application. The FAIRness of the output of the method, the FAIRified data and metadata, was evaluated using the FAIR Evaluation Services. RESULTS: We successfully applied our FAIRification method to the VASCA registry. Data entered on eCRFs is automatically transformed into machine-readable data and can be accessed and queried using SPARQL queries in the FAIR Data Point. Twenty-one FAIR Evaluator tests pass and one test regarding the metadata persistence policy fails, since this policy is not in place yet. CONCLUSION: In this study, we developed a novel method for de novo FAIRification via an EDC system. Its application in the VASCA registry and the automated FAIR evaluation show that the method can be used to make clinical research data FAIR when they are entered in an eCRF without any intervention from data management and data entry personnel. Due to the generic approach and developed tooling, we believe that our method can be used in other registries and clinical trials as well.

Natural language processing algorithms for mapping clinical text fragments onto ontology concepts: a systematic review and recommendations for future studies.

BACKGROUND: Free-text descriptions in electronic health records (EHRs) can be of interest for clinical research and care optimization. However, free text cannot be readily interpreted by a computer and, therefore, has limited value. Natural Language Processing (NLP) algorithms can make free text machine-interpretable by attaching ontology concepts to it. However, implementations of NLP algorithms are not evaluated consistently. Therefore, the objective of this study was to review the current methods used for developing and evaluating NLP algorithms that map clinical text fragments onto ontology concepts. To standardize the evaluation of algorithms and reduce heterogeneity between studies, we propose a list of recommendations. METHODS: Two reviewers examined publications indexed by Scopus, IEEE, MEDLINE, EMBASE, the ACM Digital Library, and the ACL Anthology. Publications reporting on NLP for mapping clinical text from EHRs to ontology concepts were included. Year, country, setting, objective, evaluation and validation methods, NLP algorithms, terminology systems, dataset size and language, performance measures, reference standard, generalizability, operational use, and source code availability were extracted. The studies' objectives were categorized by way of induction. These results were used to define recommendations. RESULTS: Two thousand three hundred fifty five unique studies were identified. Two hundred fifty six studies reported on the development of NLP algorithms for mapping free text to ontology concepts. Seventy-seven described development and evaluation. Twenty-two studies did not perform a validation on unseen data and 68 studies did not perform external validation. Of 23 studies that claimed that their algorithm was generalizable, 5 tested this by external validation. A list of sixteen recommendations regarding the usage of NLP systems and algorithms, usage of data, evaluation and validation, presentation of results, and generalizability of results was developed. CONCLUSION: We found many heterogeneous approaches to the reporting on the development and evaluation of NLP algorithms that map clinical text to ontology concepts. Over one-fourth of the identified publications did not perform an evaluation. In addition, over one-fourth of the included studies did not perform a validation, and 88% did not perform external validation. We believe that our recommendations, alongside an existing reporting standard, will increase the reproducibility and reusability of future studies and NLP algorithms in medicine.

Automated SNOMED CT concept and attribute relationship detection through a web-based implementation of cTAKES.

BACKGROUND: Information in Electronic Health Records is largely stored as unstructured free text. Natural language processing (NLP), or Medical Language Processing (MLP) in medicine, aims at extracting structured information from free text, and is less expensive and time-consuming than manual extraction. However, most algorithms in MLP are institution-specific or address only one clinical need, and thus cannot be broadly applied. In addition, most MLP systems do not detect concepts in misspelled text and cannot detect attribute relationships between concepts. The objective of this study was to develop and evaluate an MLP application that includes generic algorithms for the detection of (misspelled) concepts and of attribute relationships between them. METHODS: An implementation of the MLP system cTAKES, called DIRECT, was developed with generic SNOMED CT concept filter, concept relationship detection, and attribute relationship detection algorithms and a custom dictionary. Four implementations of cTAKES were evaluated by comparing 98 manually annotated oncology charts with the output of DIRECT. The F1-score was determined for named-entity recognition and attribute relationship detection for the concepts 'lung cancer', 'non-small cell lung cancer', and 'recurrence'. The performance of the four implementations was compared with a two-tailed permutation test. RESULTS: DIRECT detected lung cancer and non-small cell lung cancer concepts with F1-scores between 0.828 and 0.947 and between 0.862 and 0.933, respectively. The concept recurrence was detected with a significantly higher F1-score of 0.921, compared to the other implementations, and the relationship between recurrence and lung cancer with an F1-score of 0.857. The precision of the detection of lung cancer, non-small cell lung cancer, and recurrence concepts were 1.000, 0.966, and 0.879, compared to precisions of 0.943, 0.967, and 0.000 in the original implementation, respectively. CONCLUSION: DIRECT can detect oncology concepts and attribute relationships with high precision and can detect recurrence with significant increase in F1-score, compared to the original implementation of cTAKES, due to the usage of a custom dictionary and a generic concept relationship detection algorithm. These concepts and relationships can be used to encode clinical narratives, and can thus substantially reduce manual chart abstraction efforts, saving time for clinicians and researchers.

For which clinical rules do doctors want decision support, and why? A survey of Dutch general practitioners.

Despite the promise of decision support for improving care, alerts are often overridden or ignored. We evaluated Dutch general practitioners' intention to accept decision support in a proposed implementation based on clinical rules regarding care for elderly patients, and their reasons for wanting or not wanting support. We developed a survey based on literature and structured interviews and distributed it to all doctors who would receive support in the proposed implementation (n = 43), of which 65 percent responded. The survey consisted of six questions for each of 20 clinical rules. Despite concerns about interruption, doctors tended to choose more interruptive forms of support. Doctors wanted support when they felt the rule represented minimal care, perceived a need to improve care, and felt responsible for the action and that they might forget to perform the action; doctors declined support due to feeling that it was unnecessary and due to concerns about interruption.

Acceptance and barriers pertaining to a general practice decision support system for multiple clinical conditions: A mixed methods evaluation.

BACKGROUND: Many studies have investigated the use of clinical decision support systems as a means to improve care, but have thus far failed to show significant effects on patient-related outcomes. We developed a clinical decision support system that attempted to address issues that were identified in these studies. The system was implemented in Dutch general practice and was designed to be both unobtrusive and to respond in real time. Despite our efforts, usage of the system was low. In the current study we perform a mixed methods evaluation to identify remediable barriers which led to disappointing usage rates for our system. METHODS: A mixed methods evaluation employing an online questionnaire and focus group. The focus group was organized to clarify free text comments and receive more detailed feedback from general practitioners. Topics consisted of items based on results from the survey and additional open questions. RESULTS: The response rate for the questionnaire was 94%. Results from the questionnaire and focus group can be summarized as follows: The system was perceived as interruptive, despite its design. Participants felt that there were too many recommendations and that the relevance of the recommendations varied. Demographic based recommendations (e.g. age) were often irrelevant, while specific risk-based recommendations (e.g. diagnosis) were more relevant. The other main barrier to use was lack of time during the patient visit. CONCLUSION: These results are likely to be useful to other researchers who are attempting to address the problems of interruption and alert fatigue in decision support.

An email-based intervention to improve the number and timeliness of letters sent from the hospital outpatient clinic to the general practitioner: A pair-randomized controlled trial.

OBJECTIVE: Letters from the hospital to the general practitioner are important for maintaining continuity of care. Although doctors feel letters are important, they are often not written on time. To improve the number and timeliness of letters sent from the hospital outpatient department to the general practitioner using an email-based intervention evaluated in a randomized controlled trial. MATERIALS AND METHODS: Users were interviewed to determine the requirements for the intervention. Due to high between-doctor variation at baseline, doctors were matched for baseline performance and pair-randomized. The effectiveness of the intervention was assessed using meta-analytic methods. The primary outcome was the number of patient visits which should have generated a letter that had a letter by 90 days after the visit. Satisfaction was assessed with an anonymous survey. RESULTS: The intervention consisted of a monthly email reminder for each doctor containing a list of his or her patients who were (over)due for a letter. Doctors in the intervention group had 21% fewer patient visits which did not have a letter by 90 days (OR = 5.7, p = 0.0020). Satisfaction with the system was very high. DISCUSSION: This study examines the effect of a simple reminder in absence of other interventions, and provides an example of an effective non-interruptive decision support intervention. CONCLUSION: A simple email reminder improved the number and timeliness of letters from the outpatient department to the general practitioner, and was viewed as a useful service by its users.

Dementia incidence trend over 1992-2014 in the Netherlands: Analysis of primary care data.

BACKGROUND: Recent reports have suggested declining age-specific incidence rates of dementia in high-income countries over time. Improved education and cardiovascular health in early age have been suggested to be bringing about this effect. The aim of this study was to estimate the age-specific dementia incidence trend in primary care records from a large population in the Netherlands. METHODS AND FINDINGS: A dynamic cohort representative of the Dutch population was composed using primary care records from general practice registration networks (GPRNs) across the country. Data regarding dementia incidence were obtained using general-practitioner-recorded diagnosis of dementia within the electronic health records. Age-specific dementia incidence rates were calculated for all persons aged 60 y and over; negative binomial regression analysis was used to estimate the time trend. Nine out of eleven GPRNs provided data on more than 800,000 older people for the years 1992 to 2014, corresponding to over 4 million person-years and 23,186 incident dementia cases. The annual growth in dementia incidence rate was estimated to be 2.1% (95% CI 0.5% to 3.8%), and incidence rates were 1.08 (95% CI 1.04 to 1.13) times higher for women compared to men. Despite their relatively low numbers of person-years, the highest age groups contributed most to the increasing trend. There was no significant overall change in incidence rates since the start of a national dementia program in 2003 (-0.025; 95% CI -0.062 to 0.011). Increased awareness of dementia by patients and doctors in more recent years may have influenced dementia diagnosis by general practitioners in electronic health records, and needs to be taken into account when interpreting the data. CONCLUSIONS: Within the clinical records of a large, representative sample of the Dutch population, we found no evidence for a declining incidence trend of dementia in the Netherlands. This could indicate true stability in incidence rates, or a balance between increased detection and a true reduction. Irrespective of the exact rates and mechanisms underlying these findings, they illustrate that the burden of work for physicians and nurses in general practice associated with newly diagnosed dementia has not been subject to substantial change in the past two decades. Hence, with the ageing of Western societies, we still need to anticipate a dramatic absolute increase in dementia occurrence over the years to come.

Effectiveness and usage of a decision support system to improve stroke prevention in general practice: A cluster randomized controlled trial.

BACKGROUND: Adherence to guidelines pertaining to stroke prevention in patients with atrial fibrillation is poor. Decision support systems have shown promise in increasing guideline adherence. AIMS: To improve guideline adherence with a non-obtrusive clinical decision support system integrated in the workflow. Secondly, we seek to capture reasons for guideline non-adherence. DESIGN AND SETTING: A cluster randomized controlled trial in Dutch general practices. METHOD: A decision support system was developed that implemented properties positively associated with effectiveness: real-time, non-interruptive and based on data from electronic health records. Recommendations were based on the Dutch general practitioners guideline for atrial fibrillation that uses the CHA2DS2-VAsc for stroke risk stratification. Usage data and responses to the recommendations were logged. Effectiveness was measured as adherence to the guideline. We used a chi square to test for group differences and a mixed effects model to correct for clustering and baseline adherence. RESULTS: Our analyses included 781 patients. Usage of the system was low (5%) and declined over time. In total, 76 notifications received a response: 58% dismissal and 42% acceptance. At the end of the study, both groups had improved, by 8% and 5% respectively. There was no statistically significant difference between groups (Control: 50%, Intervention: 55% P = 0.23). Clustered analysis revealed similar results. Only one usable reasons for non-adherence was captured. CONCLUSION: Our study could not demonstrate the effectiveness of a decision support system in general practice, which was likely due to lack of use. Our findings should be used to develop next generation decision support systems that are effective in the challenging setting of general practice.

Metrics of Arterial Hyperoxia and Associated Outcomes in Critical Care.

OBJECTIVE: Emerging evidence has shown the potential risks of arterial hyperoxia, but the lack of a clinical definition and methodologic limitations hamper the interpretation and clinical relevance of previous studies. Our purpose was to evaluate previously used and newly constructed metrics of arterial hyperoxia and systematically assess their association with clinical outcomes in different subgroups in the ICU. DESIGN: Observational cohort study. SETTING: Three large tertiary care ICUs in the Netherlands. PATIENTS: A total of 14,441 eligible ICU patients. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: In total, 295,079 arterial blood gas analyses, including the PaO2, between July 2011 and July 2014 were extracted from the patient data management system database. Data from all admissions with more than one PaO2 measurement were supplemented with anonymous demographic and admission and discharge data from the Dutch National Intensive Care Evaluation registry. Mild hyperoxia was defined as PaO2 between 120 and 200 mm Hg; severe hyperoxia as PaO2 greater than 200 mm Hg. Characteristics of existing and newly constructed metrics for arterial hyperoxia were examined, and the associations with hospital mortality (primary outcome), ICU mortality, and ventilator-free days and alive at day 28 were retrospectively analyzed using regression models in different subgroups of patients. Severe hyperoxia was associated with higher mortality rates and fewer ventilator-free days in comparison to both mild hyperoxia and normoxia for all metrics except for the worst PaO2. Adjusted effect estimates for conditional mortality were larger for severe hyperoxia than for mild hyperoxia. This association was found both within and beyond the first 24 hours of admission and was consistent for large subgroups. The largest point estimates were found for the exposure identified by the average PaO2, closely followed by the median PaO2, and these estimates differed substantially between subsets. Time spent in hyperoxia showed a linear and positive relationship with hospital mortality. CONCLUSIONS: Our results suggest that we should limit the PaO2 levels of critically ill patients within a safe range, as we do with other physiologic variables. Analytical metrics of arterial hyperoxia should be judiciously considered when interpreting and comparing study results and future studies are needed to validate our findings in a randomized fashion design.

Reasons for intentional guideline non-adherence: A systematic review.

BACKGROUND: Reasons for intentional non-adherence to guidelines are largely unknown. The objective of this systematic review was to gain insight into and categorize reasons for intentional non-adherence and their validity. Non-adherence might be a conscious choice by either the clinician or the patient, and is not influenced by external factors (e.g. lack of knowledge or resources). We use the term intentional non-adherence to describe this class of reasons for not following guideline recommendations. METHODS: Two independent reviewers examined MEDLINE citations for studies that investigated reasons for guideline non-adherence. The obtained articles were assessed for relevance and quality. Our search yielded 2912 articles, of which 16 matched our inclusion criteria and quality requirements. We planned to determine an overall ranking of categories of non-adherence. RESULTS: Seven studies investigated clinical reasons and performed adjudication, while nine studies did not perform adjudication. Non-adherence varied between 8.2% and 65.3%. Meta-analysis proved unfeasible due to heterogeneity of study methodologies. The percentage of reasons deemed valid by adjudication ranged from 6.6% to 93.6%. Guideline non-adherence was predominantly valid; contra-indications and patient preference were most often reported as reasons for intentional non-adherence. CONCLUSION: We found a wide range of rates of non-adherence to clinical guidelines. This non-adherence is often supported by valid reasons, mainly related to contra-indications and patient preference. Therefore, we submit that many guideline deviations are intentional and these deviations do not necessarily impact quality of care.

HIV indicator condition-guided testing to reduce the number of undiagnosed patients and prevent late presentation in a high-prevalence area: a case-control study in primary care.

OBJECTIVES: Recent guidelines advocate accelerated provider-initiated HIV testing by general practitioners (GPs). We aimed to identify the number of patient consultations in six general practices in the South-East of Amsterdam, and the incidence of HIV indicator conditions reported in their medical files prior to diagnosis. METHODS: A cross-sectional search in an electronic general practice database. We used a case-control design to identify those conditions most associated with an HIV-positive status. RESULTS: We included 102 HIV cases diagnosed from 2002 to 2012, and matched them with 299 controls. In the year prior to HIV diagnosis, 61.8% of cases visited their GP at least once, compared with 38.8% of controls. In the 5 years prior to HIV diagnosis, 58.8% of HIV cases had exhibited an HIV indicator condition, compared with 7.4% of controls. The most common HIV-related conditions were syphilis and gonorrhoea. The most common HIV-related symptoms were weight loss, lymphadenopathy and peripheral neuropathy. During this period, average HIV prevalence among people aged 15-59 years increased from 0.4% to 0.9%. CONCLUSIONS: This study revealed many opportunities for HIV indicator condition-guided testing in primary care. As yet, however, HIV indicator conditions are not exploited as triggers for early HIV testing.

Health information-seeking behavior of seniors who use the Internet: a survey.

BACKGROUND: The Internet is viewed as an important source for health information and a medium for patient empowerment. However, little is known about how seniors use the Internet in relation to other sources for health information. OBJECTIVE: The aim was to determine which information resources seniors who use the Internet use and trust for health information, which sources are preferred, and which sources are used by seniors for different information needs. METHODS: Questions from published surveys were selected based on their relevance to the study objectives. The Autonomy Preference Index was used to assess information needs and preferences for involvement in health decisions. Invitation to participate in this online survey was sent to the email list of a local senior organization (298 addresses) in the Netherlands. RESULTS: There were 118 respondents with a median age of 72 years (IQR 67-78 years). Health professionals, pharmacists, and the Internet were the most commonly used and trusted sources of health information. Leaflets, television, newspapers, and health magazines were also important sources. Respondents who reported higher use of the Internet also reported higher use of other sources (P<.001). Use of health professionals, pharmacists, leaflets, telephone, television, and radio were not significantly different; use of all other resources was significantly higher in frequent Internet users. When in need of health information, preferred sources were the Internet (46/105, 43.8%), other sources (eg, magazines 38/105, 36.2%), health professionals (18/105, 17.1%), and no information seeking (3/105, 2.8%). Of the 51/107 respondents who indicated that they had sought health information in the last 12 months, 43 sought it after an appointment, 23 were preparing for an appointment, and 20 were deciding if an appointment was needed. The source used varied by the type of information sought. The Internet was used most often for symptoms (27/42, 64%), prognosis (21/31, 68%), and treatment options (23/41, 62%), whereas health professionals were asked for additional information on medications (20/36, 56%), side effects (17/36, 47%), coping (17/31, 55%), practical care (12/14, 86%), and nutrition/exercise (18/30, 60%). CONCLUSIONS: For these seniors who use the Internet, the Internet was a preferred source of health information. Seniors who report higher use of the Internet also report higher use of other information resources and were also the primary consumers of paper-based resources. Respondents most frequently searched for health information after an appointment rather than to prepare for an appointment. Resources used varied by health topic. Future research should seek to confirm these findings in a general elderly population, investigate how seniors seek and understand information on the Internet, and investigate how to reach seniors who prefer not to use the Internet for health information.

From assessment to improvement of elderly care in general practice using decision support to increase adherence to ACOVE quality indicators: study protocol for randomized control trial.

BACKGROUND: Previous efforts such as Assessing Care of Vulnerable Elders (ACOVE) provide quality indicators for assessing the care of elderly patients, but thus far little has been done to leverage this knowledge to improve care for these patients. We describe a clinical decision support system to improve general practitioner (GP) adherence to ACOVE quality indicators and a protocol for investigating impact on GPs' adherence to the rules. DESIGN: We propose two randomized controlled trials among a group of Dutch GP teams on adherence to ACOVE quality indicators. In both trials a clinical decision support system provides un-intrusive feedback appearing as a color-coded, dynamically updated, list of items needing attention. The first trial pertains to real-time automatically verifiable rules. The second trial concerns non-automatically verifiable rules (adherence cannot be established by the clinical decision support system itself, but the GPs report whether they will adhere to the rules). In both trials we will randomize teams of GPs caring for the same patients into two groups, A and B. For the automatically verifiable rules, group A GPs receive support only for a specific inter-related subset of rules, and group B GPs receive support only for the remainder of the rules. For non-automatically verifiable rules, group A GPs receive feedback framed as actions with positive consequences, and group B GPs receive feedback framed as inaction with negative consequences. GPs indicate whether they adhere to non-automatically verifiable rules. In both trials, the main outcome measure is mean adherence, automatically derived or self-reported, to the rules. DISCUSSION: We relied on active end-user involvement in selecting the rules to support, and on a model for providing feedback displayed as color-coded real-time messages concerning the patient visiting the GP at that time, without interrupting the GP's workflow with pop-ups. While these aspects are believed to increase clinical decision support system acceptance and its impact on adherence to the selected clinical rules, systems with these properties have not yet been evaluated. TRIAL REGISTRATION: Controlled Trials NTR3566.

Improving stroke prevention in patients with atrial fibrillation.

BACKGROUND: Patients with atrial fibrillation (AF) are at increased risk for stroke. Antithrombotic treatment reduces this risk. Antithrombotic treatment consists of either administration of oral anticoagulants (OAC) or the provision of an antiplatelet drug. International guidelines provide advice on the preferred treatment, thereby balancing the risks and benefits of OAC. However, adherence to these guidelines is reported to be as low as 50%. There is paucity in research on why adherence rates are low. Recent studies have shown decision support systems can improve guideline adherence. We investigate the use of a clinical decision support system to improve guideline adherence among general practitioners (GPs) treating patients with AF and study reasons for guideline non-adherence. METHODS/DESIGN: The study is a randomized controlled trial, which is performed among Dutch general practitioners. Initially, GPs in the vicinity of the Academic Medical Center (AMC) in Amsterdam will be included, after which other practices will be recruited. We have developed a novel decision support system that displays a list with pending messages for the on-screen medical record in real time. Messages are generated on a server that evaluates a decision rule based on the atrial fibrillation guideline of the Dutch College of General Practitioners. By interacting with the list, messages can be opened for a description and explanation, or be ignored. GPs are allocated into three groups: 1) control group; 2) intervention group A, in which messages can be ignored without justification; and 3) intervention group B, in which messages can only be ignored with justification.Our main outcome measure is the between-group difference in the proportion of patients receiving antithrombotic prescriptions in adherence to the Dutch GP guideline for atrial fibrillation. Secondary outcomes are reasons GPs state for deviating from the guideline and the effect on guideline adherence of requiring justification when ignoring a message. DISCUSSION: This paper describes the protocol for a cluster randomized trial to study the effects of a clinical decision support system in patients with atrial fibrillation. The system is characterized by a non-interruptive presentation and real-time messages that are updated after each relevant action the GP performs. TRIAL REGISTRATION: This trial is registered with the Dutch Trial Register under registration number 3570.

Frequency and risk factors for under- and over-treatment in stroke prevention for patients with non-valvular atrial fibrillation in general practice.

OBJECTIVE: To determine adequacy of antithrombotic treatment in patients with non-valvular atrial fibrillation. To determine risk factors for under- and over-treatment. DESIGN: Retrospective, cross-sectional study of electronic health records from 36 general practitioners in 2008. SETTING: General practice in the Netherlands. SUBJECTS: Primary care physicians (n = 36) and patients (n = 981) aged 65 years and over. MAIN OUTCOME MEASURES: Rates of adequate, under and over-treatment, risk factors for under and over-treatment. RESULTS: Of the 981 included patients with a mean of age 78, 18% received no antithrombotic treatment (under-treatment), 13% received antiplatelet drugs and 69% received oral anticoagulation (OAC). Further, 43% of the included patients were treated adequately, 26% were under-treated, and 31% were over-treated. Patients with a previous ischaemic stroke were at high risk for under-treatment (OR 2.4, CI 1.6-3.5), whereas those with contraindications for OAC were at high risk for over-treatment (OR 37.0, CI 18.1-79.9). Age over 75 (OR 0.2, CI: 0.1-0.3]), diabetes (OR 0.1, CI: 0.1-0.3), heart failure (OR 0.2, CI: 0.1-0.3), hypertension (OR 0.1, CI: 0.1-0.2) and previous ischaemic stroke (OR 0.04, CI: 0.02-0.11) protected against over-treatment. CONCLUSIONS: In general practice, CHADS2-criteria are being used, but the antithrombotic treatment of patients with atrial fibrillation frequently deviates from guidelines on this topic. Patients with previous stroke are at high risk of not being prescribed OAC. Contraindications for OAC, however, seem to be frequently overlooked.

Psychometric properties of the dutch version of the core measure of melancholia.

BACKGROUND: The CORE measure was designed to assess psychomotor symptoms and the probability of melancholia in depressed people. We tested the inter-rater reliability and validity of the Dutch version of the CORE. METHODS: Thirty-seven elderly, depressed in-patients were studied. The CORE, Salpêtrière Retardation Rating Scale (SRRS), Quick Inventory of Depressive Symptoms-self-report version (QIDS) and Montgomery Asberg Depression Rating Scale (MADRS) were administered. The inter-rater reliability of the CORE was examined by calculating the intra-class correlation coefficient (ICC) of agreement between five independent raters. Construct validity was assessed by calculating Spearman rho (ρ) correlations between CORE and SRRS, QIDS and MADRS measure scores. RESULTS: The ICC for total CORE scores was 0.80, while, for the CORE sub-scales the ICCs were 0.74 for non-interactiveness, 0.70 for retardation and 0.79 for agitation, indicating high inter-rater reliability. Associations between the CORE and SRRS measures supported the validity of the CORE as a measure of psychomotor disturbance, while correlations between the CORE agitation sub-scale and agitation items derived from the QIDS and MADRS were low to moderate. LIMITATIONS: Both the sample size and the comparator measures of psychomotor disturbance (especially agitation) may have compromised construct validity analyses. CONCLUSIONS: High inter-rater reliability was demonstrated for the Dutch CORE measure. Its validity as a measure of psychomotor disturbance was supported in analyses involving total CORE scores.