PCSK9 inhibitors and ezetimibe for the reduction of cardiovascular events: a clinical practice guideline with risk-stratified recommendations.

CLINICAL QUESTION: In adults with low density lipoprotein (LDL) cholesterol levels >1.8 mmol/L (>70 mg/dL) who are already taking the maximum dose of statins or are intolerant to statins, should another lipid-lowering drug be added, either a proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor or ezetimibe, to reduce the risk of major cardiovascular events? If so, which drug is preferred? Having decided to use one, should we add the other lipid-lowering drug? CURRENT PRACTICE: Most guidelines emphasise LDL cholesterol targets in their recommendations for prescribing PCSK9 inhibitors and/or ezetimibe in adults at high risk of experiencing a major adverse cardiovascular event. However, to achieve these goals in very high risk patients with statins alone is almost impossible, so physicians are increasingly considering other lipid-lowering drugs solely for achieving LDL cholesterol treatment goals rather than for achieving important absolute cardiovascular risk reduction. Most guidelines do not systematically assess the cardiovascular benefits of adding PCSK9 inhibitors and/or ezetimibe for all risk groups across primary and secondary prevention, nor do they report, in accordance with explicit judgments of assumed patients' values and preferences, absolute benefits and harms and potential treatment burdens. RECOMMENDATIONS: The guideline panel provided mostly weak recommendations, which means we rely on shared decision making when applying these recommendations. For adults already using statins, the panel suggests adding a second lipid-lowering drug in people at very high and high cardiovascular risk but recommends against adding it in people at low cardiovascular risk. For adults who are intolerant to statins, the panel recommends using a lipid-lowering drug in people at very high and high cardiovascular risk but against adding it in those at low cardiovascular risk. When choosing to add another lipid-lowering drug, the panel suggests ezetimibe in preference to PCSK9 inhibitors. The panel suggests further adding a PCSK9 inhibitor to ezetimibe for adults already taking statins at very high risk and those at very high and high risk who are intolerant to statins. HOW THIS GUIDELINE WAS CREATED: An international panel including patients, clinicians, and methodologists produced these recommendations following standards for trustworthy guidelines and using the GRADE approach. The panel identified four risk groups of patients (low, moderate, high, and very high cardiovascular risk) and primarily applied an individual patient perspective in moving from evidence to recommendations, though societal issues were a secondary consideration. The panel considered the balance of benefits and harms and burdens of starting a PCSK9 inhibitor and/or ezetimibe, making assumptions of adults' average values and preferences. Interactive evidence summaries and decision aids accompany multi-layered recommendations, developed in an online authoring and publication platform (www.magicapp.org) that also allows re-use and adaptation. THE EVIDENCE: A linked systematic review and network meta-analysis (14 trials including 83 660 participants) of benefits found that PCSK9 inhibitors or ezetimibe probably reduce myocardial infarctions and stroke in patients with very high and high cardiovascular risk, with no impact on mortality (moderate to high certainty evidence), but not in those with moderate and low cardiovascular risk. PCSK9 inhibitors may have similar effects to ezetimibe on reducing non-fatal myocardial infarction or stroke (low certainty evidence). These relative benefits were consistent, but their absolute magnitude varied based on cardiovascular risk in individual patients (for example, for 1000 people treated with PCSK9 inhibitors in addition to statins over five years, benefits ranged from 2 fewer strokes in the lowest risk to 21 fewer in the highest risk). Two systematic reviews on harms found no important adverse events for these drugs (moderate to high certainty evidence). PCSK9 inhibitors require injections that sometimes result in injection site reactions (best estimate 15 more per 1000 in a 5 year timeframe), representing a burden and harm that may matter to patients. The MATCH-IT decision support tool allows you to interact with the evidence and your patients across the alternative options: https://magicevidence.org/match-it/220504dist-lipid-lowering-drugs/. UNDERSTANDING THE RECOMMENDATIONS: The stratification into four cardiovascular risk groups means that, to use the recommendations, physicians need to identify their patient's risk first. We therefore suggest, specific to various geographical regions, using some reliable risk calculators that estimate patients' cardiovascular risk based on a mix of known risk factors. The largely weak recommendations concerning the addition of ezetimibe or PCSK9 inhibitors reflect what the panel considered to be a close balance between small reductions in stroke and myocardial infarctions weighed against the burdens and limited harms.Because of the anticipated large variability of patients' values and preferences, well informed choices warrant shared decision making. Interactive evidence summaries and decision aids linked to the recommendations can facilitate such shared decisions. The strong recommendations against adding another drug in people at low cardiovascular risk reflect what the panel considered to be a burden without important benefits. The strong recommendation for adding either ezetimibe or PCSK9 inhibitors in people at high and very high cardiovascular risk reflect a clear benefit.The panel recognised the key uncertainty in the evidence concerning patient values and preferences, namely that what most people consider important reductions in cardiovascular risks, weighed against burdens and harms, remains unclear. Finally, availability and costs will influence decisions when healthcare systems, clinicians, or people consider adding ezetimibe or PCSK9 inhibitors.

Performance of five rapid serological tests in mild-diseased subjects using finger prick blood for exposure assessment to SARS-CoV-2.

OBJECTIVES: Assess the performance of five SARS-CoV-2 rapid serological tests (RST) using finger prick (FP) blood on-site to evaluate their usability for exposure assessment in population-based seroprevalence studies. STUDY DESIGN: Since cross-reactivity with common cold human coronaviruses occurs, serological testing includes a risk of false-positive results. Therefore, the selected cohort for RST-validation was based on combined immunoassay (presence of specific antibodies) and RT-qPCR (presence of SARS-CoV-2) data. RST-performance for FP blood and serum was assessed by performing each RST in two groups, namely SARSCoV- 2 positive (n=108) and negative healthcare workers (n=89). Differences in accuracy and positive and negative predictive values (PPV, NPV) were calculated for a range (1-50%) of SARS-CoV-2 prevalence estimates. RESULTS: The OrientGene showed overall acceptable performance, with sensitivities of 94.4% and 100%, and specificities of 96.6% and 94.4%, using FP blood and serum, respectively. Although three RST reach optimal specificities (100%), the OrientGene clearly outperforms in sensitivity. At a SARS-CoV-2 prevalence rate of 40%, this RST outperforms the other tests in NPV (96.3%) and reaches comparable PPV (94.9%). Although the specificity of the Covid-Presto is excellent when using FP blood or serum (100% and 97.8%, respectively), its sensitivity decreases when using FP blood (76.9%) compared to serum (98.1%). CONCLUSIONS: Performances of the evaluated RST differ largely. Only one out of five RST (OrientGene) had acceptable sensitivity and specificity using FP blood. Therefore, the latter could be used for seroprevalence studies in a high-prevalence situation. The OrientGene, which measures anti-RBD antibodies, can be valuable after vaccination as well.

Evaluation of a comprehensive pre-procedural screening protocol for COVID-19 in times of a high SARS CoV-2 prevalence: a prospective cross-sectional study.

BACKGROUND: To minimise the risk of COVID-19 transmission, an ambulant screening protocol for COVID-19 in patients before admission to the hospital was implemented, combining the SARS CoV-2 reverse-transcriptase polymerase chain reaction (RT-PCR) on a nasopharyngeal swab, a chest computed tomography (CT) and assessment of clinical symptoms. The aim of this study was to evaluatethe diagnostic yield and the proportionality of this pre-procedural screeningprotocol. METHODS: In this mono-centre, prospective, cross-sectional study, all patients admitted to the hospital between 22nd April 2020 until 14th May 2020 for semi-urgent surgery, haematological or oncological treatment, or electrophysiological investigationunderwent a COVID-19 screening 2 days before their procedure. At a 2-week follow-up, the presence of clinical symptoms was evaluated by telephone as a post-hoc evaluation of the screening approach.Combined positive RT-PCR assay and/or positive chest CT was used as gold standard. Post-procedural outcomes of all patients diagnosed positive for COVID-19 were assessed. RESULTS: In total,528 patients were included of which 20 (3.8%) were diagnosed as COVID-19 positive and 508 (96.2%) as COVID-19 negative. 11 (55.0%) of COVID-19 positive patients had only a positive RT-PCR assay, 3 (15.0%) had only a positive chest CT and 6 (30%) had both a positive RT-PCR assay and chest CT. 10 out of 20 (50.0%) COVID-19 positive patients reported no single clinical symptom at the screening. At 2 week follow-up, 50% of these patients were still asymptomatic. 37.5% of all COVID-19 negative patients were symptomatic at screening. In the COVID-19 negative group without symptoms at screening, 78 (29.3%) patients developed clinical symptoms at a 2-week follow-up. CONCLUSION: This study suggests that routine chest CT and assessment of self-reported symptoms have limited value in the preprocedural COVID-19 screening due to low sensitivity and/or specificity.

Diagnosis of COVID-19 Based on Symptomatic Analysis of Hospital Healthcare Workers in Belgium: Observational Study in a Large Belgian Tertiary Care Center During Early COVID-19 Outbreak.

OBJECTIVE: To identify early symptoms allowing rapid appraisal of infection with SARS-CoV-2 among healthcare workers of a large Belgian hospital. METHODS: Healthcare workers with mild symptoms of an acute respiratory tract infection were systematically screened on clinical characteristics of corona virus disease 2019 (COVID-19). A nasopharyngeal swab was taken and analyzed by real-time Reverse-Transcription-Polymerase-Chain-Reaction (rRT-PCR). RESULTS: Fifty percent of 373 workers tested COVID-19 positive. The symptoms cough (82%), headache (78%), myalgia (70%), loss of smell or taste (40%), and fever more than or equal to 37.5 °C (76%) were significantly higher among those infected. CONCLUSION: Where each individual symptom contributes to the clinical evaluation of possible infection, it is the combination of COVID-19 symptoms that could allow for a rapid diagnostic appraisal of the disease in a high prevalence setting. Early transmission control is important at the onset of an epidemic.

Six years of measuring patient experiences in Belgium: Limited improvement and lack of association with improvement strategies.

OBJECTIVE: To examine trends in patient experiences in the period 2014-2019, describe improvement strategies implemented by hospitals in the same period, and study associations between patient experiences and implemented strategies. DESIGN: Multi-center retrospective region-wide observational design. SETTING: Flanders, Belgium. PARTICIPANTS: 44 out of 46 Flemish acute-care hospitals publicly reporting patient experiences via the Flemish Patient Survey (FPS). MAIN OUTCOME MEASURE(S): Primary outcomes were the two global FPS ratings: percentage of patients rating the hospital 9 or 10 and percentage of patients definitely recommending the hospital. Secondary outcomes were the average top-box score percentages for each of the 8 remaining dimensions of the FPS. RESULTS: Between 2014 and 2019, there was a significant improvement in patients scoring the hospital 9 or 10 (56% to 61%) and patients definitely recommending (67% to 70%) the hospital. Significant increases in patient experiences over time were also observed in other dimensions, except for the dimension discharge. Hospital key informants reported various improvement strategies related to patient experiences with care and the FPS. Feedback to nursing wards (n = 44, 100%) and clinicians (n = 39, 89%) were most common. Overall, most improvement strategies were not or only weakly associated with patient experience ratings in 2019 and changes in ratings over time. Still, positive associations were discovered between the strategies 'nursing ward interventions' and 'hospital wide education' and recommendation of the hospital. CONCLUSIONS: Patient experiences have improved modestly in Flemish acute-care hospitals. Hospitals report to have invested in patient experience improvement strategies but positive associations between such strategies and FPS scores are weak, although there is potential in further exploring nursing ward interventions and hospital wide education. Hospitals should continue their efforts to improve the patient's experience, but with a more targeted approach, taking the lessons learned on the efficacy of strategies into consideration.

Clinical decision support improves the appropriateness of laboratory test ordering in primary care without increasing diagnostic error: the ELMO cluster randomized trial.

BACKGROUND: Inappropriate laboratory test ordering poses an important burden for healthcare. Clinical decision support systems (CDSS) have been cited as promising tools to improve laboratory test ordering behavior. The objectives of this study were to evaluate the effects of an intervention that integrated a clinical decision support service into a computerized physician order entry (CPOE) on the appropriateness and volume of laboratory test ordering, and on diagnostic error in primary care. METHODS: This study was a pragmatic, cluster randomized, open-label, controlled clinical trial. SETTING: Two hundred eighty general practitioners (GPs) from 72 primary care practices in Belgium. PATIENTS: Patients aged ≥ 18 years with a laboratory test order for at least one of 17 indications: cardiovascular disease management, hypertension, check-up, chronic kidney disease (CKD), thyroid disease, type 2 diabetes mellitus, fatigue, anemia, liver disease, gout, suspicion of acute coronary syndrome (ACS), suspicion of lung embolism, rheumatoid arthritis, sexually transmitted infections (STI), acute diarrhea, chronic diarrhea, and follow-up of medication. INTERVENTIONS: The CDSS was integrated into a computerized physician order entry (CPOE) in the form of evidence-based order sets that suggested appropriate tests based on the indication provided by the general physician. MEASUREMENTS: The primary outcome of the ELMO study was the proportion of appropriate tests over the total number of ordered tests and inappropriately not-requested tests. Secondary outcomes of the ELMO study included diagnostic error, test volume, and cascade activities. RESULTS: CDSS increased the proportion of appropriate tests by 0.21 (95% CI 0.16-0.26, p < 0.0001) for all tests included in the study. GPs in the CDSS arm ordered 7 (7.15 (95% CI 3.37-10.93, p = 0.0002)) tests fewer per panel. CDSS did not increase diagnostic error. The absolute difference in proportions was a decrease of 0.66% (95% CI 1.4% decrease-0.05% increase) in possible diagnostic error. CONCLUSIONS: A CDSS in the form of order sets, integrated within the CPOE improved appropriateness and decreased volume of laboratory test ordering without increasing diagnostic error. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02950142 , registered on October 25, 2016.

Impact of implementation of an individualised thromboprophylaxis protocol in critically ill ICU patients with COVID-19: A longitudinal controlled before-after study.

INTRODUCTION: An individualised thromboprophylaxis was implemented in critically ill patients suffering from coronavirus disease 2019 (COVID-19) pneumonia to reduce mortality and improve clinical outcome. The aim of this study was to evaluate the effect of this intervention on clinical outcome. METHODS: In this mono-centric, controlled, before-after study, all consecutive adult patients with confirmed COVID-19 pneumonia admitted to ICU from March 13th to April 20th 2020 were included. A thromboprophylaxis protocol, including augmented LMWH dosing, individually tailored with anti-Xa measurements and twice-weekly ultrasonography screening for DVT, was implemented on March 31th 2020. Primary endpoint is one-month mortality. Secondary outcomes include two-week and three-week mortality, the incidence of VTE, acute kidney injury and continuous renal replacement therapy (CRRT). Multiple regression modelling was used to correct for differences between the two groups. RESULTS: 46 patients were included in the before group, 26 patients in the after group. One month mortality decreased from 39.13% to 3.85% (p < 0.001). After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)). The cumulative incidence of VTE and CRRT was respectively 41% and 30.4% in the before group and dropped to 15% (p = 0.03) and 3.8% (p = 0.01), respectively. After correction for confounding variables, risk of VTE (p = 0.03, 6.01 (1.13, 32.12)) and CRRT (p = 0.02, OR 19.21 (1.44, 255.86)) remained significantly higher in the before group. CONCLUSION: Mortality, cumulative risk of VTE and need for CRRT may be significantly reduced in COVID-19 patients by implementation of a more aggressive thromboprophylaxis protocol. Future research should focus on confirmation of these results in a randomized design and on uncovering the mechanisms underlying these observations. REGISTRATION NUMBER: NCT04394000.

Computerized clinical decision support system for diabetes in primary care does not improve quality of care: a cluster-randomized controlled trial.

BACKGROUND: The EBMeDS system is the computerized clinical decision support (CCDS) system of EBPNet, a national computerized point-of-care information service in Belgium. There is no clear evidence of more complex CCDS systems to manage chronic diseases in primary care practices (PCPs). The objective of this study was to assess the effectiveness of EBMeDS use in improving diabetes care. METHODS: A cluster-randomized trial with before-and-after measurements was performed in Belgian PCPs over 1 year, from May 2017 to May 2018. We randomly assigned 51 practices to either the intervention group (IG), to receive the EBMeDS system, or to the control group (CG), to receive usual care. Primary and secondary outcomes were the 1-year pre- to post-implementation change in HbA1c, LDL cholesterol, and systolic and diastolic blood pressure. Composite patient and process scores were calculated. A process evaluation was added to the analysis. Results were analyzed at 6 and 12 months. Linear mixed models and logistic regression models based on generalized estimating equations were used where appropriate. RESULTS: Of the 51 PCPs that were enrolled and randomly assigned (26 PCPs in the CG and 25 in the IG), 29 practices (3815 patients) were analyzed in the study: 2464 patients in the CG and 1351 patients in the IG. No change differences existed between groups in primary or secondary outcomes. Change difference between CG and IG after 1-year follow-up was - 0.09 (95% CI - 0.18; 0.01, p-value = 0.06) for HbA1c; 1.76 (95% CI - 0.46; 3.98, p-value = 0.12) for LDL cholesterol; and 0.13 (95% CI - 0.91; 1.16, p-value = 0.81) and 0.12 (95% CI - 1.25;1.49, p-value = 0.86) for systolic and diastolic blood pressure respectively. The odds ratio of the IG versus the CG for the probability of no worsening and improvement was 1.09 (95% CI 0.73; 1.63, p-value = 0.67) for the process composite score and 0.74 (95% CI 0.49; 1.12, p-value = 0.16) for the composite patient score. All but one physician was satisfied with the EBMeDS system. CONCLUSIONS: The CCDS system EBMeDS did not improve diabetes care in Belgian primary care. The lack of improvement was mainly caused by imperfections in the organizational context of Belgian primary care for chronic disease management and shortcomings in the system requirements for the correct use of the EBMeDS system (e.g., complete structured records). These shortcomings probably caused low-use rates of the system. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01830569, Registered 12 April 2013.

Electronic Laboratory Medicine ordering with evidence-based Order sets in primary care (ELMO study): protocol for a cluster randomised trial.

BACKGROUND: Laboratory testing is an important clinical act with a valuable role in screening, diagnosis, management and monitoring of diseases or therapies. However, inappropriate laboratory test ordering is frequent, burdening health care spending and negatively influencing quality of care. Inappropriate tests may also result in false-positive results and potentially cause excessive downstream activities. Clinical decision support systems (CDSSs) have shown promising results to influence the test-ordering behaviour of physicians and to improve appropriateness. Order sets, a form of CDSS where a limited set of evidence-based tests are proposed for a series of indications, integrated in a computerised physician order entry (CPOE) have been shown to be effective in reducing the volume of ordered laboratory tests but convincing evidence that they influence appropriateness is lacking. The aim of this study is to evaluate the effect of order sets on the quality and quantity of laboratory test orders by physicians. We also aim to evaluate the effect of order sets on diagnostic error and explore the effect on downstream or cascade activities. METHODS: We will conduct a cluster randomised controlled trial in Belgian primary care practices. The study is powered to measure two outcomes. We will primarily measure the influence of our CDSS on the appropriateness of laboratory test ordering. Additionally, we will also measure the influence on diagnostic error. We will also explore the effects of our intervention on cascade activities due to altered results of inappropriate tests. DISCUSSION: We have designed a study that should be able to demonstrate whether the CDSS aimed at diagnostic testing is not only able to influence appropriateness but also safe with respect to diagnostic error. These findings will influence a lager, nationwide implementation of this CDSS. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02950142 .

New Instrument to Measure Hospital Patient Experiences in Flanders.

Implementing a standardized patient experience survey may initiate a process to apply pressure on hospitals to attend to improving patient experiences. In Flanders, Belgium, the Flemish Patient Survey was developed between 2011 and 2015. A preliminary version was developed from a scoping review and patient and expert focus groups, and included 27 items for eight hypothesized dimensions: 'preparing for hospital stay', 'information and communication', 'coordination', 'respect', 'privacy', 'safe care', pain management', and 'participation'. Exploratory factor analysis for 1076 patients in 17 hospitals found that the data did not fit the dimensions. Adaptations in item wording and response categories were based on the US Hospital Consumer Assessment of Healthcare Providers and Systems. The revised version showed excellent model fit in 22,143 patients in 37 hospitals. Multiple group analysis pointed to evidence of measurement invariance over time across mode of administration, type of nursing unit, and various patient characteristics. Fostering a collaborative approach thus proved successful in implementing a standardized patient experience survey. The most recent findings (2016) illustrate substandard performance and a need for patient-mix adjustment. The Flemish government developed a dedicated website to make findings publicly available and the federal government currently considers patient experiences in devising a pay-for-quality scheme.

The Effects of Computerized Clinical Decision Support Systems on Laboratory Test Ordering: A Systematic Review.

CONTEXT: - Inappropriate laboratory test ordering has been shown to be as high as 30%. This can have an important impact on quality of care and costs because of downstream consequences such as additional diagnostics, repeat testing, imaging, prescriptions, surgeries, or hospital stays. OBJECTIVE: - To evaluate the effect of computerized clinical decision support systems on appropriateness of laboratory test ordering. DATA SOURCES: - We used MEDLINE, Embase, CINAHL, MEDLINE In-Process and Other Non-Indexed Citations, Clinicaltrials.gov, Cochrane Library, and Inspec through December 2015. Investigators independently screened articles to identify randomized trials that assessed a computerized clinical decision support system aimed at improving laboratory test ordering by providing patient-specific information, delivered in the form of an on-screen management option, reminder, or suggestion through a computerized physician order entry using a rule-based or algorithm-based system relying on an evidence-based knowledge resource. Investigators extracted data from 30 papers about study design, various study characteristics, study setting, various intervention characteristics, involvement of the software developers in the evaluation of the computerized clinical decision support system, outcome types, and various outcome characteristics. CONCLUSIONS: - Because of heterogeneity of systems and settings, pooled estimates of effect could not be made. Data showed that computerized clinical decision support systems had little or no effect on clinical outcomes but some effect on compliance. Computerized clinical decision support systems targeted at laboratory test ordering for multiple conditions appear to be more effective than those targeted at a single condition.

Delivering Diabetes Education through Nurse-Led Telecoaching. Cost-Effectiveness Analysis.

BACKGROUND: People with diabetes have a high risk of developing micro- and macrovascular complications associated with diminished life expectancy and elevated treatment costs. Patient education programs can improve diabetes control in the short term, but their cost-effectiveness is uncertain. Our study aimed to analyze the lifelong cost-effectiveness of a nurse-led telecoaching program compared to usual care in people with type 2 diabetes from the perspective of the Belgian healthcare system. METHODS: The UKPDS Outcomes Model was populated with patient-level data from an 18-month randomized clinical trial in the Belgian primary care sector involving 574 participants; trial data were extrapolated to 40 years; Quality Adjusted Life Years (QALYs), treatment costs and Incremental Cost-Effectiveness Ratio (ICER) were calculated for the entire cohort and the subgroup with poor glycemic control at baseline ("elevated HbA1c subgroup") and the associated uncertainty was explored. RESULTS: The cumulative mean QALY (95% CI) gain was 0.21 (0.13; 0.28) overall and 0.56 (0.43; 0.68) in elevated HbA1c subgroup; the respective incremental costs were €1,147 (188; 2,107) and €2,565 (654; 4,474) and the respective ICERs €5,569 (€677; €15,679) and €4,615 (1,207; 9,969) per QALY. In the scenario analysis, repeating the intervention for lifetime had the greatest impact on the cost-effectiveness and resulted in the mean ICERs of €13,034 in the entire cohort and €7,858 in the elevated HbA1c subgroup. CONCLUSION: Taking into account reimbursement thresholds applied in West-European countries, nurse-led telecoaching of people with type 2 diabetes may be considered highly cost-effective within the Belgian healthcare system. TRIAL REGISTRATION: NCT01612520.

Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial.

BACKGROUND: Despite the efforts of the healthcare community to improve the quality of diabetes care, about 50% of people with type 2 diabetes do not reach their treatment targets, increasing the risk of future micro-and macro-vascular complications. Diabetes self-management education has been shown to contribute to better disease control. However, it is not known which strategies involving educational programs are cost-effective. Telehealth applications might support chronic disease management. Transferability of successful distant patient self-management support programs to the Belgian setting needs to be confirmed by studies of a high methodological quality. "The COACH Program" was developed in Australia as target driven educational telephone delivered intervention to support people with different chronic conditions. It proved to be effective in patients with coronary heart disease after hospitalization. Clinical and cost-effectiveness of The COACH Program in people with type 2 diabetes in Belgium needs to be assessed. METHODS/DESIGN: Randomized controlled trial in patients with type 2 diabetes. Patients were selected based on their medication consumption data and were recruited by their sickness fund. They were randomized to receive either usual care plus "The COACH Program" or usual care alone. The study will assess the difference in outcomes between groups. The primary outcome measure is the level of HbA1c. The secondary outcomes are: Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Blood Pressure, body mass index, smoking status; proportion of people at target for HbA1c, LDL-Cholesterol and Blood Pressure; self-perceived health status, diabetes-specific emotional distress and satisfaction with diabetes care. The follow-up period is 18 months. Within-trial and modeled cost-utility analyses, to project effects over life-time horizon beyond the trial duration, will be undertaken from the perspective of the health care system if the intervention is effective. DISCUSSION: The study will enhance our understanding of the potential of telehealth in diabetes management in Belgium. Research on the clinical effectiveness and the cost-effectiveness is essential to support policy makers in future reimbursement and implementation decisions.

Evidence-based prehospital management of severe traumatic brain injury: a comparative analysis of current clinical practice guidelines.

OBJECTIVE: This study appraised the completeness and level of evidence behind prehospital recommendations in clinical practice guidelines (CPGs) for management of severe traumatic brain injury (TBI). Differences and similarities in key recommendations for prehospital emergency care were assessed between current CPGs. METHODS: A systematic search identified current evidence-based CPGs for the management of severe TBI. The identified CPGs were screened for prehospital recommendations. Finally, an evaluation of the completeness and level of evidence for each of the identified recommendations was carried out. A review of the literature identified additional evidence. Designs of the retrieved publications were considered and classified according to the GRADE levels of evidence. RESULTS: This study identified 12 current CPGs for the management of patients after traumatic brain injury. Of these, twenty-one prehospital recommendations were selected. Only a few CPGs made recommendations on temperature management and ventilation patterns. Statements on prehospital transport and advanced airway management were common to all of the guidelines. Statements on initial treatment demonstrated the greatest variability. The literature review identified several relevant publications not included in the CPGs even after we controlled for the indicated time-intervals of their literature search. In addition, evidence from more recent trials published outside the search-interval of the clinical practice guidelines was found. CONCLUSIONS: The use of current guidelines on traumatic brain injury will not always facilitate decisions about best or most appropriate practice for prehospital practitioners. The amount of recommended prehospital interventions varied considerably, and there was large content variation in prehospital recommendations in these guidelines. Not all evidence was taken into account and not all CPGs were up-to-date.

Evidence-based health care policy in reimbursement decisions: lessons from a series of six equivocal case-studies.

CONTEXT: Health care technological evolution through new drugs, implants and other interventions is a key driver of healthcare spending. Policy makers are currently challenged to strengthen the evidence for and cost-effectiveness of reimbursement decisions, while not reducing the capacity for real innovations. This article examines six cases of reimbursement decision making at the national health insurance authority in Belgium, with outcomes that were contested from an evidence-based perspective in scientific or public media. METHODS: In depth interviews with key stakeholders based on the adapted framework of Davies allowed us to identify the relative impact of clinical and health economic evidence; experience, expertise & judgment; financial impact & resources; values, ideology & political beliefs; habit & tradition; lobbyists & pressure groups; pragmatics & contingencies; media attention; and adoption from other payers & countries. FINDINGS: Evidence was not the sole criterion on which reimbursement decisions were based. Across six equivocal cases numerous other criteria were perceived to influence reimbursement policy. These included other considerations that stakeholders deemed crucial in this area, such as taking into account the cost to the patient, and managing crisis scenarios. However, negative impacts were also reported, in the form of bypassing regular procedures unnecessarily, dominance of an opinion leader, using information selectively, and influential conflicts of interest. CONCLUSIONS: 'Evidence' and 'negotiation' are both essential inputs of reimbursement policy. Yet, purposely selected equivocal cases in Belgium provide a rich source to learn from and to improve the interaction between both. We formulated policy recommendations to reconcile the impact of all factors identified. A more systematic approach to reimburse new care may be one of many instruments to resolve the budgetary crisis in health care in other countries as well, by separating what is truly innovative and value for money from additional 'waste'.

Feasibility and impact of an evidence-based electronic decision support system for diabetes care in family medicine: protocol for a cluster randomized controlled trial.

BACKGROUND: In Belgium, the construction of the national electronic point-of-care information service, EBMPracticeNet, was initiated in 2011 to optimize quality of care by promoting evidence-based decision-making. The collaboration of the government, healthcare providers, Evidence-Based Medicine (EBM) partners, and vendors of Electronic Health Records (EHR) is unique to this project. All Belgian healthcare professionals get free access to an up-to-date database of validated Belgian and nearly 1,000 international guidelines, incorporated in a portal that also provides EBM information from sources other than guidelines, including computerized clinical decision support that is integrated in the EHRs. METHODS: The study is a cluster-randomized trial with before/after measurements conducted in Belgian family medicine. Physicians' practices will be randomly assigned to the intervention or control group in a 1:1 ratio, to receive either the EBMeDS reminders or to follow the usual care process. Randomization will be performed by a statistical consultant with an electronic random list generator, anonymously for the researchers. The follow-up period of the study will be 12 months with interim analysis points at 3, 6 and 9 months. Primary outcome is the one-year pre- to post-implementation change in HbA1c. Patients will not be informed about the intervention. Data analysts will be kept blinded to the allocation. DISCUSSION: The knowledge obtained in this study will be useful for further integration in other Belgian software packages. Users' perceptions and process evaluation will provide information for improving the feasibility of the system. TRIAL REGISTRATION: The trial is registered with the ClinicalTrials.gov registry: NCT01830569.

EBMPracticeNet: A Bilingual National Electronic Point-Of-Care Project for Retrieval of Evidence-Based Clinical Guideline Information and Decision Support.

BACKGROUND: In Belgium, the construction of a national electronic point-of-care information service, EBMPracticeNet, was initiated in 2011 to optimize quality of care by promoting evidence-based decision-making. The collaboration of the government, health care providers, evidence-based medicine (EBM) partners, and vendors of electronic health records (EHR) is unique to this project. All Belgian health care professionals get free access to an up-to-date database of validated Belgian and nearly 1000 international guidelines, incorporated in a portal that also provides EBM information from other sources than guidelines, including computerized clinical decision support that is integrated in the EHRs. OBJECTIVE: The objective of this paper was to describe the development strategy, the overall content, and the management of EBMPracticeNet which may be of relevance to other health organizations creating national or regional electronic point-of-care information services. METHODS: Several candidate providers of comprehensive guideline solutions were evaluated and one database was selected. Translation of the guidelines to Dutch and French was done with translation software, post-editing by translators and medical proofreading. A strategy is determined to adapt the guideline content to the Belgian context. Acceptance of the computerized clinical decision support tool has been tested and a randomized controlled trial is planned to evaluate the effect on process and patient outcomes. RESULTS: Currently, EBMPracticeNet is in "work in progress" state. Reference is made to the results of a pilot study and to further planned research including a randomized controlled trial. CONCLUSIONS: The collaboration of government, health care providers, EBM partners, and vendors of EHRs is unique. The potential value of the project is great. The link between all the EHRs from different vendors and a national database held on a single platform that is controlled by all EBM organizations in Belgium are the strengths of EBMPracticeNet.

Human computation as a new method for evidence-based knowledge transfer in Web-based guideline development groups: proof of concept randomized controlled trial.

BACKGROUND: Guideline developers use different consensus methods to develop evidence-based clinical practice guidelines. Previous research suggests that existing guideline development techniques are subject to methodological problems and are logistically demanding. Guideline developers welcome new methods that facilitate a methodologically sound decision-making process. Systems that aggregate knowledge while participants play a game are one class of human computation applications. Researchers have already proven that these games with a purpose are effective in building common sense knowledge databases. OBJECTIVE: We aimed to evaluate the feasibility of a new consensus method based on human computation techniques compared to an informal face-to-face consensus method. METHODS: We set up a randomized design to study 2 different methods for guideline development within a group of advanced students completing a master of nursing and obstetrics. Students who participated in the trial were enrolled in an evidence-based health care course. We compared the Web-based method of human-based computation (HC) with an informal face-to-face consensus method (IC). We used 4 clinical scenarios of lower back pain as the subject of the consensus process. These scenarios concerned the following topics: (1) medical imaging, (2) therapeutic options, (3) drugs use, and (4) sick leave. Outcomes were expressed as the amount of group (dis)agreement and the concordance of answers with clinical evidence. We estimated within-group and between-group effect sizes by calculating Cohen's d. We calculated within-group effect sizes as the absolute difference between the outcome value at round 3 and the baseline outcome value, divided by the pooled standard deviation. We calculated between-group effect sizes as the absolute difference between the mean change in outcome value across rounds in HC and the mean change in outcome value across rounds in IC, divided by the pooled standard deviation. We analyzed statistical significance of within-group changes between round 1 and round 3 using the Wilcoxon signed rank test. We assessed the differences between the HC and IC groups using Mann-Whitney U tests. We used a Bonferroni adjusted alpha level of .025 in all statistical tests. We performed a thematic analysis to explore participants' arguments during group discussion. Participants completed a satisfaction survey at the end of the consensus process. RESULTS: Of the 135 students completing a master of nursing and obstetrics, 120 participated in the experiment. We formed 8 HC groups (n=64) and 7 IC groups (n=56). The between-group comparison demonstrated that the human computation groups obtained a greater improvement in evidence scores compared to the IC groups, although the difference was not statistically significant. The between-group effect size was 0.56 (P=.30) for the medical imaging scenario, 0.07 (P=.97) for the therapeutic options scenario, and 0.89 (P=.11) for the drug use scenario. We found no significant differences in improvement in the degree of agreement between HC and IC groups. Between-group comparisons revealed that the HC groups showed greater improvement in degree of agreement for the medical imaging scenario (d=0.46, P=.37) and the drug use scenario (d=0.31, P=.59). Very few evidence arguments (6%) were quoted during informal group discussions. CONCLUSIONS: Overall, the use of the IC method was appropriate as long as the evidence supported participants' beliefs or usual practice, or when the availability of the evidence was sparse. However, when some controversy about the evidence existed, the HC method outperformed the IC method. The findings of our study illustrate the importance of the choice of the consensus method in guideline development. Human computation could be an acceptable methodology for guideline development specifically for scenarios in which the evidence shows no resonance with participants' beliefs. Future research is needed to confirm the results of this study and to establish practical significance in a controlled setting of multidisciplinary guideline panels during real-life guideline development.

Can training improve laypersons helping behaviour in first aid? A randomised controlled deception trial.

BACKGROUND: There is limited evidence indicating that laypersons trained in first aid provide better help, but do not help more often than untrained laypersons. This study investigated the effect of conventional first aid training versus conventional training plus supplementary training aimed at decreasing barriers to helping. METHODS: The authors conducted a randomised controlled trial. After 24 h of conventional first aid training, the participants either attended an experimental lesson to reduce barriers to helping or followed a control lesson. The authors used a deception test to measure the time between the start of the unannounced simulated emergency and seeking help behaviour and the number of particular helping actions. RESULTS: The authors randomised 72 participants to both groups. 22 participants were included in the analysis for the experimental group and 36 in the control group. The authors found no statistically or clinically significant differences for any of the outcome measures. The time until seeking help (geometrical mean and 95% CI) was 55.5 s (42.9 to 72.0) in the experimental group and 56.5 s (43.0 to 74.3) in the control group. 57% of the participants asked a bystander to seek help, 40% left the victim to seek help themselves and 3% did not seek any help. CONCLUSION: Supplementary training on dealing with barriers to helping did not alter the helping behaviour. The timing and appropriateness of the aid provided can be improved. TRIAL REGISTRATION: The authors registered this trial at ClinicalTrials.gov as NCT00954161.

Family physicians' perceptions and use of electronic clinical decision support during the first year of implementation.

An electronic decision support system (the EBMeDS system) was integrated in one of the Electronic Medical Records (EMR) of Belgian family physicians (Feb 2010). User acceptance of the system is considered as a necessary condition for the effective implementation of any IT project. Facilitators, barriers and issues of non-acceptance need to be understood in view of a successful implementation and to minimize unexpected adoption behavior. Objectives of the study were the assessment of users' perceptions towards the recently implemented EBMeDS system, the investigation of user-interactions with the system and possible relationships between perceptions and use. A mixed evaluation approach was performed consisting of a qualitative and a quantitative analysis. The technology acceptance model of UTAUT was used as a structural model for the development of our questionnaire to identify factors that may account for acceptance and use of the EBMeDS system (seven-point Likert scales). A quantitative analysis of computer-recorded user interactions with the system was performed for an evaluation period of 3 months to assess the actual use of the system. Qualitative and quantitative analysis were linked to each other. Thirty-nine family physicians (12 %) completed the survey. The majority of respondents (66 %) had a positive attitude towards the system in general. Mean intention to keep using the system was high (5,91 ± 1,33). Their perception of the ease of use of the system (mean 5,04 ± 1,41), usefulness (mean 4,69 ± 1,35) and facilitating conditions (4,43 ± 1,13) was in general positive. Only 0,35 % of reminders were requested on demand, the other 99,62 % of reminders displayed automatically. Detailed guidelines (long) were requested for 0,47 % of reminders automatically shown versus 16,17 % of reminders on request. The script behind the reminders was requested for 8,4 % of reminders automatically shown versus 13,6 % of reminders on request. The majority of respondents demonstrated a relatively high degree of acceptance towards the EBMeDS system. Although the majority of respondents was in general positive towards the ease of use of the system, usefulness and facilitating conditions, part of the statements gave rather mixed results and could be identified as important points of interest for future implementation initiatives and system improvements. It has to be stressed that our population consisted of a convenience sample of early adopters, willing to answer a questionnaire. The willingness to adopt the system depends on the willingness to use ICPC coding. As such, the quality of reminding partly depends on the quality of coding. There is a need to reach a larger population of physicians (including physicians who never used the system or stopped using the system) to validate the results of this survey.