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.

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.

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.

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.

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.

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.

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.

The attitude of Flemish occupational health physicians toward evidence-based occupational health and clinical practice guidelines.

PURPOSE: To identify the attitude of occupational health physicians toward evidence-based occupational health (EBOH) and clinical practice guidelines (CPGs); to determine their ability to access, retrieve and appraise the health evidence and the barriers to applying evidence to practice. METHODS: A cross-sectional survey study was carried out among all Dutch-speaking occupational health physicians in Belgium (584 physicians could be reached). RESULTS: A response rate of 25.5% was achieved. The majority of respondents were positive toward EBOH and CPGs. Most respondents were less confident in basic skills of EBM, except for their searching skills. Perceived barriers to applying evidence to practice were mainly time and lack of EBM skills. CONCLUSIONS: Belgian occupational health physicians are interested in the implementation of EBOH in their daily occupational practice and have a general knowledge of EBM. However, there are barriers in the legislative framework, the education and the information infrastructure, which first have to be removed. The time has come for the responsible authorities to take educational initiatives and to take a huge leap forward in the integration of EBOH into occupational practice.

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.

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.

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.

Effectiveness of nonresuscitative first aid training in laypersons: a systematic review.

STUDY OBJECTIVE: This study reviewed evidence on the effects of nonresuscitative first aid training on competence and helping behavior in laypersons. METHODS: We identified randomized and nonrandomized controlled trials and interrupted time series on nonresuscitative first aid training for laypersons by using 12 databases (including MEDLINE, EMBASE, and PsycINFO), hand searching, reference checking, and author communication. Two reviewers independently evaluated selected studies with the Cochrane Effective Practice and Organisation of Care Review Group quality criteria. One reviewer extracted data with a standard form and another checked them. In anticipation of substantial heterogeneity across studies, we elected a descriptive summary of the included studies. RESULTS: We included 4 studies, 3 of which were randomized trials. We excluded 11 studies on quality issues. Two studies revealed that participants trained in first aid demonstrated higher written test scores than controls (poisoning first aid: relative risk 2.11, 95% confidence interval [CI] 1.64 to 2.72; various first aid cases: mean difference 4.75, 95% CI 3.02 to 6.48). Two studies evaluated helping responses during unannounced simulations. First aid training improved the quality of help for a bleeding emergency (relative risk 25.94; 95% CI 3.60 to 186.93), not the rate of helping (relative risk 1.13; 95% CI 0.88 to 1.45). Training in first aid and helping behavior increased the helping rates in a chest pain emergency compared with training in first aid only (relative risk 2.80; 95% CI 1.05 to 7.50) or controls (relative risk 3.81; 95% CI 0.98 to 14.89). Participants trained in first aid only did not help more than controls (relative risk 1.36; 95% CI 0.28 to 6.61). CONCLUSION: First aid programs that also train participants to overcome inhibitors of emergency helping behavior could lead to better help and higher helping rates.

The attitude of Belgian social insurance physicians towards evidence-based practice and clinical practice guidelines.

BACKGROUND: Evidence-based medicine has broadened its scope and is starting to reach insurance medicine. Although still in its initial stages, physicians in the area of insurance medicine should keep up-to-date with the evidence on various diseases in order to correctly assess disability and to give appropriate advice about health care reimbursement. In order to explore future opportunities of evidence-based medicine to improve daily insurance medicine, there is a need for qualitative studies to better understand insurance physicians' perceptions of EBM. The present study was designed to identify the attitude of insurance physicians towards evidence-based medicine and clinical practice guidelines, and to determine their ability to access, retrieve and appraise the health evidence and the barriers for applying evidence to practice. METHODS: A cross-sectional survey study was carried out among all Dutch-speaking insurance physicians employed at one of the six Belgian social insurance sickness funds and at the National Institute of Disability and Health care Insurance (n = 224). Chi-square tests were used to compare nominal and ordinal variables. Student's t-tests, ANOVA, Mann-Whitney and Kruskal-Wallis were used to compare means of continuous variables for different groups. RESULTS: The response rate was 48.7%. The majority of respondents were positive towards evidence-based medicine and clinical practice guidelines. Their knowledge of EBM was rather poor. Perceived barriers for applying evidence to practice were mainly time and lack of EBM skills. CONCLUSION: Although the majority of physicians were positive towards EBM and welcomed more guidelines, the use of evidence and clinical practice guidelines in insurance medicine is low at present. It is in the first place important to eradicate the perceived inertia which limits the use of EBM and to further investigate the EBM principles in the context of insurance medicine. Available high-quality evidence-based resources (at the moment mainly originating from other medical fields) need to be structured in a way that is useful for insurance physicians and global access to this information needs to be ensured.

Cost-effectiveness of statins in the primary prevention of cardiovascular disease: a systematic review and economic analysis for Belgium.

OBJECTIVES: 8% of total drug spending by the Belgian government goes to statins. The aim of this study is to determine the cost-effectiveness of statins for the primary prevention of cardiovascular disease (CVD) in middle-aged Belgian populations. METHODS AND RESULTS: Economic evaluations were identified in a systematic literature search and were critically appraised. Furthermore, because prices decreased drastically, a previously published model was adapted applying recent cost data from the Belgian national health insurance. Eleven full economic evaluations were identified. Nine studies compared statins with no treatment and presented heterogeneous results. If alternative interventions, such as smoking cessation or low-dose aspirin treatment were included in the analysis, statin therapy became less cost-effective. Prescribing the cheapest statin on the Belgian market (< Euro 90 medication cost per year) resulted in an incremental cost of Euro 29,173 per life-year gained (LYG) in a male high-risk group aged 60 compared to low-dose aspirin. The incremental cost in a male moderate-risk group aged 50 was Euro 87,022/LYG. Low-dose aspirin was more cost-effective ranging from Euro 3,854/LYG to Euro 29,509/LYG compared to smoking cessation therapy. Smoking cessation therapy was the most cost-effective intervention, providing savings compared to no treatment. CONCLUSIONS: In Belgium, the cost-effectiveness of statins for the primary prevention of CVD is rather elevated in comparison with low-dose aspirin, even if the cheapest statin is prescribed. From an economic point of view, prevention with low-dose aspirin is more cost-effective and may present a first choice in primary prevention. Smoking cessation, which is a dominant strategy, should be encouraged at all times.

International comparison of orthotic brace prices.

This study compared market prices (i.e. third-party reimbursement and patient co-payment) of prefabricated neck, wrist and knee braces in Belgium, France, the Netherlands, Ontario (Canada) and the UK. Data were collected through contacts with health authorities, health insurance funds, manufacturers and distributors. Market prices varied substantially between countries, indicating that manufacturers adapt their price setting strategy to the policy environment and the structure of the brace market of a country. Belgian prices tended to exceed prices in other countries for the selected neck, wrist and knee braces. There seems to be scope for reducing Belgian prices of selected braces.

Ostomy appliance prices in Europe.

OBJECTIVE: This article aims to compare market prices (i.e., third-party reimbursement and patient co-payment) of one-piece and two-piece colostomy, ileostomy and ureterostomy appliances in Belgium, Denmark, England and the Netherlands in 2005. METHODS: Data were collected through contacts with health authorities, health insurance companies, manufacturers, industry associations and distributors. The price difference between Belgium and another country was expressed as a proportion of the Belgian price. RESULTS: A total of 64 out of the 72 ostomy appliance products considered were cheaper in Belgium. Prices of one-piece colostomy appliances and two-piece ileostomy appliances were consistently lower in Belgium. The highest prices of ostomy appliances were observed in the Netherlands. Sixteen out of 20 products and 21 out of 25 products were more expensive in Denmark and England, respectively, than in Belgium. Colostomy appliances were more expensive in England than in Belgium. CONCLUSIONS: Market prices varied substantially between countries, indicating that manufacturers adapt their pricing strategy to the policy environment existing in the ostomy appliance market of each country. Also, there appears to be scope for reducing prices in some countries.

Trastuzumab in early stage breast cancer: a cost-effectiveness analysis for Belgium.

OBJECTIVES: Although trastuzumab is traditionally used in metastatic breast cancer treatment, studies reported on the efficacy and safety of trastuzumab in adjuvant setting for the treatment of early stage breast cancer in HER2+ tumors. We estimated the cost-effectiveness and budget impact of reimbursing trastuzumab in this indication from a payer's perspective. METHODS: We constructed a health economic model. Long-term consequences of preventing patients to progress to metastatic breast cancer and side effects such as congestive heart failure were taken into account. Uncertainty was handled applying probabilistic modeling and through probabilistic sensitivity analyses. RESULTS: In the HERA scenario, applying an arbitrary threshold of euro30000 per life-year gained, early stage breast cancer treatment with trastuzumab is cost-effective for 9 out of 15 analyzed subgroups (according to age and stage). In contrast, treatment according to the FinHer scenario is cost-effective in 14 subgroups. Furthermore, the FinHer regimen is most of the times cost saving with an average incremental cost of euro668, euro-1045, and euro-6869 for respectively stages I, II and III breast cancer patients whereas the HERA regimen is never cost saving due to the higher initial treatment costs. CONCLUSIONS: The model shows better cost-effectiveness for the 9-week initial treatment (FinHer) compared to no trastuzumab treatment than for the 1-year post-chemotherapy treatment (HERA). Both from a medical and an economic point of view, the 9-week initial treatment regimen with trastuzumab shows promising results and justifies the initiation of a large comparative trial with a 1-year regimen.

Reforming the Belgian market for orthotic braces: what can we learn from the international experience?

OBJECTIVES: This article aims to review regulation governing outpatient orthotic braces (neck, wrist and knee braces) in France, the Netherlands and Sweden with a view to reforming the Belgian market. METHODS: Information about the regulatory framework was derived from an analysis of legal texts and a survey completed by national experts. RESULTS: Strategies to keep down prices include public procurement in Sweden, maximum prices in France, and exclusion of expensive braces from reimbursement in the Netherlands. Reimbursement is linked to a medical indication or a chronic condition in France, the Netherlands and Sweden. To gain reimbursement, the cost-effectiveness of orthotic braces needs to be demonstrated in France and the Netherlands. Orthotic braces tend to be initially prescribed by a specialist physician and distributed by orthotists, medical equipment shops and/or community pharmacies. CONCLUSIONS: Extensive government intervention exists in the outpatient orthotic brace market in the countries studied. Our recommendations to reform the Belgian market for prefabricated orthotic braces are to separate reimbursement for service provision from reimbursement for braces; to set prices by means of a tendering process or an international price comparison; and to make reimbursement conditional on effectiveness and cost-effectiveness of braces.