A Risk Analysis Method to Evaluate the Impact of a Computerized Provider Order Entry System on Patient Safety

Objectives: Quantitative evaluation of safety after the implementation of a computerized provider order entry (CPOE) system, stratification of residual risks to drive future developments. Design: Comparative risk analysis of the drug prescription process before and after the implementation of CPOE system, according to the Failure Modes, Effects and Criticality Analysis (FMECA) method. Measurements: The failure modes were defined and their criticality indices calculated on the basis of the likelihood of occurrence, potential severity for patients, and detection probability. Criticality indices of handwritten and electronic prescriptions were compared, the acceptability of residual risks was discussed. Further developments were proposed and their potential impact on the safety was estimated. Results: The sum of criticality indices of 27 identified failure modes was 3813 for the handwritten prescription, 2930 (−23%) for CPOE system, and 1658 (−57%) with 14 enhancements. The major safety improvements were observed for errors due to ambiguous, incomplete or illegible orders (−245 points), wrong dose determination (−217) and interactions (−196). Implementation of targeted pop-ups to remind treatment adaptation (−189), vital signs (−140), and automatic edition of documents needed for the dispensation (−126) were the most promising proposed improvements. Conclusion: The impact of a CPOE system on patient safety strongly depends on the implemented functions and their ergonomics. The use of risk analysis helps to quantitatively evaluate the relationship between a system and patient safety and to build a strategy for continuous quality improvement, by selecting the most appropriate improvements to the syste

JAMA Neurol

Importance: Moderately effective therapies (METs) have been the main treatment in pediatric-onset multiple sclerosis (POMS) for years. Despite the expanding use of highly effective therapies (HETs), treatment strategies for POMS still lack consensus.Objective: To assess the real-world association of HET as an index treatment compared with MET with disease activity.Design, setting, and participants: This was a retrospective cohort study conducted from January 1, 2010, to December 8, 2022, until the last recorded visit. The median follow-up was 5.8 years. A total of 36 French MS centers participated in the Observatoire Français de la Sclérose en Plaques (OFSEP) cohort. Of the total participants in OFSEP, only treatment-naive children with relapsing-remitting POMS who received a first HET or MET before adulthood and at least 1 follow-up clinical visit were included in the study. All eligible participants were included in the study, and none declined to participate.Exposure: HET or MET at treatment initiation.Main outcomes and measures: The primary outcome was the time to first relapse after treatment. Secondary outcomes were annualized relapse rate (ARR), magnetic resonance imaging (MRI) activity, time to Expanded Disability Status Scale (EDSS) progression, tertiary education attainment, and treatment safety/tolerability. An adapted statistical method was used to model the logarithm of event rate by penalized splines of time, allowing adjustment for effects of covariates that is sensitive to nonlinearity and interactions.Results: Of the 3841 children (5.2% of 74 367 total participants in OFSEP), 530 patients (mean [SD] age, 16.0 [1.8] years; 364 female [68.7%]) were included in the study. In study patients, both treatment strategies were associated with a reduced risk of first relapse within the first 2 years. HET dampened disease activity with a 54% reduction in first relapse risk (adjusted hazard ratio [HR], 0.46; 95% CI, 0.31-0.67; P < .001) sustained over 5 years, confirmed on MRI activity (adjusted odds ratio [OR], 0.34; 95% CI, 0.18-0.66; P = .001), and with a better tolerability pattern than MET. The risk of discontinuation at 2 years was 6 times higher with MET (HR, 5.97; 95% CI, 2.92-12.20). The primary reasons for treatment discontinuation were lack of efficacy and intolerance. Index treatment was not associated with EDSS progression or tertiary education attainment (adjusted OR, 0.51; 95% CI, 0.24-1.10; P = .09).Conclusions and relevance: Results of this cohort study suggest that compared with MET, initial HET in POMS was associated with a reduction in the risk of first relapse with an optimal outcome within the first 2 years and was associated with a lower rate of treatment switching and a better midterm tolerance in children. These findings suggest prioritizing initial HET in POMS, although long-term safety studies are needed.Observatoire Français de la Sclérose en Plaque

Neurology

The question of the long-term safety of pregnancy is a major concern in patients with multiple sclerosis (MS), but its study is biased by reverse causation (women with higher disability are less likely to experience pregnancy). Using a causal inference approach, we aimed to estimate the unbiased long-term effects of pregnancy on disability and relapse risk in patients with MS and secondarily the short-term effects (during the perpartum and postpartum years) and delayed effects (occurring beyond 1 year after delivery). We conducted an observational cohort study with data from patients with MS followed in the Observatoire Français de la Sclérose en Plaques registry between 1990 and 2020. We included female patients with MS aged 18-45 years at MS onset, clinically followed up for more than 2 years, and with ≥3 Expanded Disease Status Scale (EDSS) measurements. Outcomes were the mean EDSS score at the end of follow-up and the annual probability of relapse during follow-up. Counterfactual outcomes were predicted using the longitudinal targeted maximum likelihood estimator in the entire study population. The patients exposed to at least 1 pregnancy during their follow-up were compared with the counterfactual situation in which, contrary to what was observed, they would not have been exposed to any pregnancy. Short-term and delayed effects were analyzed from the first pregnancy of early-exposed patients (who experienced it during their first 3 years of follow-up). We included 9,100 patients, with a median follow-up duration of 7.8 years, of whom 2,125 (23.4%) patients were exposed to at least 1 pregnancy. Pregnancy had no significant long-term causal effect on the mean EDSS score at 9 years (causal mean difference [95% CI] = 0.00 [-0.16 to 0.15]) or on the annual probability of relapse (causal risk ratio [95% CI] = 0.95 [0.93-1.38]). For the 1,253 early-exposed patients, pregnancy significantly decreased the probability of relapse during the perpartum year and significantly increased it during the postpartum year, but no significant delayed effect was found on the EDSS and relapse rate. Using a causal inference approach, we found no evidence of significantly deleterious or beneficial long-term effects of pregnancy on disability. The beneficial effects found in other studies were probably related to a reverse causation bias.Observatoire Français de la Sclérose en Plaque

DMTs and Covid-19 severity in MS: a pooled analysis from Italy and France

We evaluated the effect of DMTs on Covid-19 severity in patients with MS, with a pooled-analysis of two large cohorts from Italy and France. The association of baseline characteristics and DMTs with Covid-19 severity was assessed by multivariate ordinal-logistic models and pooled by a fixed-effect meta-analysis. 1066 patients with MS from Italy and 721 from France were included. In the multivariate model, anti-CD20 therapies were significantly associated (OR&nbsp;=&nbsp;2.05, 95%CI&nbsp;=&nbsp;1.39–3.02, p&nbsp;&lt;&nbsp;0.001) with Covid-19 severity, whereas interferon indicated a decreased risk (OR&nbsp;=&nbsp;0.42, 95%CI&nbsp;=&nbsp;0.18–0.99, p&nbsp;=&nbsp;0.047). This pooled-analysis confirms an increased risk of severe Covid-19 in patients on anti-CD20 therapies and supports the protective role of interferon

Sensibilité des codes diagnostiques saisis dans le cadre du programme de médicalisation des systèmes d information pour l identification des cas de maladie thrombo-embolique veineuse

Objectif: Evaluer la sensibilité des codes CIM-10 (dixième Classification Internationale des Maladies) issus des bases de données médico-administratives hospitalières (PMSI) dans la détection de la thrombose veineuse profonde (TVP) et de l embolie pulmonaire (EP). Protocole de l étude: Nous avons comparé les codes CIM-10 issus du PMSI avec les diagnostics issus d une étude de cohorte prospective établis selon une stratégie diagnostique validée. La sensibilité a été définie comme étant le pourcentage de patients atteints de TVP et/ou d EP identifiés par les codes CIM-10 du PMSI. Effectifs: 1375 patients suspects de TVP et/ou d EP inclus sur 25 hôpitaux en France. Résultats: La sensibilité des codes CIM-10 est de 58.0% (159/274; Intervalle de confiance 95% [IC 95%],51.9-64.1) concernant les TVP et de 88.9% (297/334; [IC 95%], 85.6-92.2) pour l EP. Selon les hôpitaux, la valeur médiane de la sensibilité pour la TVP est de 57.7% (Interquartile, 48.6-66.7; coefficient de corrélation intergroupe, 0.02; p=0.31), et de 88.9% pour l EP (interquartile,83.3-96.3; coefficient de corrélation intergroupe, 0.11; p=0.03). La sensibilité des codes CIM-10 est plus basse pour les patients ayant bénéficié d une intervention chirurgicale et pour les TVP ou les EP déclarées au cours du séjour hospitalier. Conclusion: Les codes CIM-10 des bases de données médico-administratives sont suffisamment sensibles pour détecter les patients atteints d EP. Un nombre important de patients avec TVP ne seraient pas identifiés lors de l utilisation de ce ces mêmes bases de données à des fins de surveillance ou de recherche.Objective: To estimate the sensitivity of ICD-10 hospital discharge diagnosis codes for identifying deep vein thrombosis (DVT) and pulmonary embolism (PE). Study design and Setting: We compared predefined ICD-10 discharge diagnosis codes with the diagnoses that were prospectively recorded for 1375 patients with suspected DVT or PE who were enrolled at 25 hospitals in France. Sensitivity was calculated as the percentage of patients identified by predefined ICD-10 codes among positive cases of acute symptomatic DVT or PE confirmed by objective testing. Results: The sensitivity of ICD-10 codes was 58.0% (159/274; 95% confidence interval [95% CI], 51.9 64.1) for isolated DVT and 88.9% (297/334; 95% CI, 85.6 92.2) for PE. Depending on the hospital, the median values for sensitivity were 57.7% for DVT (interquartile range, 48.6 66.7; intracluster correlation coefficient, 0.02; P=0.31) and 88.9% for PE (interquartile range, 83.3 96.3; intracluster correlation coefficient, 0.11; P=0.03). The sensitivity of ICD-10 codes was lower for surgical patients and for patients who developed PE or DVT while hospitalized. Conclusions: ICD-10 discharge diagnosis codes yield satisfactory sensitivity for identifying objectively confirmed PE. A substantial proportion of DVT cases are missed when using hospital discharge data for complication screening or research purposes.GRENOBLE1-BU Médecine pharm. (385162101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Risk Assessment for Hospital-Acquired Diseases: A Risk-Theory Approach.

International audienceWe introduce a new approach to hospital-acquired disease risk assessment from public health databases. In a spirit similar to actuarial risk theory, we define an adjustment coefficient that can quantify the risk associated with a hospital department, allowing comparisons of similar departments. The adjustment coefficient characterizes the tail of the distribution of the total patient length of stay in a department before the first disease event occurs. We show that this coefficient is the solution of a Lundberg-like equation, and we provide a nonparametric estimation procedure for this measure, based on a Cram?Lundberg approximation for the tail of the distribution. Using simulations, we provide evidence of the robustness of the approximation to various individual risk models. In addition, we illustrate the relevance of this approach by evaluating the risk associated with a standard patient safety indicator in 20 hospitals of southeastern France

Prophylactic injection of methylmetacrylate in vertebrae located between two previously cemented levels does not prevent a subsequent compression fracture in a patient with bone fragility

A 68-year-old woman with a fragility fracture of the fourth lumbar vertebra was treated with a first vertebroplasty using methylmetacrylate with an initial good pain relief. Early painful recurrent vertebral fractures led to iterative vertebroplasties. Furthermore prophylactic treatment with methylmetacrylate of a non-fractured vertebra located between two previously injected ones did not prevent its collapse. This case report underlines the lack of a clear evaluation benefit/risk ratio of these procedures in patients with non-malignant bone fragility

Outcomes for inpatients with normal findings on whole-leg ultrasonography: a prospective study.

International audienceBACKGROUND: Ultrasonography is used routinely for ruling out suspected deep vein thrombosis in hospitalized patients, although most evidence supporting this strategy is derived from the outpatient setting. This study aimed to estimate the rate of venous thromboembolism when anticoagulant therapy was withheld from inpatients with normal findings on whole-leg ultrasonography. METHODS: As part of a prospective multicenter cohort study, 1926 medical and surgical inpatients with clinically suspected deep vein thrombosis during their stay were enrolled. Ultrasonography of all lower extremities was performed by board-certified vascular medicine physicians using a standardized examination protocol. Deep vein thrombosis was detected in 395 patients (20%). Anticoagulant therapy was withheld from patients with normal findings, and 523 of them were randomly selected for follow-up. The main outcome measure was 3-month incidence of symptomatic venous thromboembolism. RESULTS: A total of 513 patients with normal findings on ultrasonography successfully completed 3 months of follow-up, 9 patients were lost to follow-up, and 1 patient received anticoagulant therapy during follow-up. Three patients (0.6%) experienced nonfatal symptomatic venous thromboembolic events confirmed by objective testing. The cause of death was judged to be possibly related to pulmonary embolism for 7 other patients (1.3%). Overall, the 3-month rate of venous thromboembolism was 1.9% (10/513; 95% confidence interval, 0.9-3.5). CONCLUSION: Although withholding anticoagulant therapy after a single negative whole-leg ultrasonography seems to be safe, up to 3.5% of inpatients may nevertheless develop venous thromboembolism in the next 3 months. Further study is warranted to determine whether this strategy is equivalent to serial compression ultrasonography limited to proximal veins

Accuracy of complete compression ultrasound in ruling out suspected deep venous thrombosis in the ambulatory setting. A prospective cohort study.

International audienceEvidence on the safety of complete compression ultrasound for ruling out deep venous thrombosis (DVT) is derived from studies conducted in tertiary care centers, although most patients with suspected DVT are managed in the ambulatory office setting. It was the objective of this study to estimate the rate of venous thromboembolism when anticoagulant therapy is withheld from ambulatory patients with normal findings on a single complete compression ultrasound. As part of a prospective cohort study, 3,871 ambulatory patients with clinically suspected DVT were enrolled by 255 board-certified vascular medicine physicians practicing in private offices in France. Compression ultrasound of the entire lower extremities was performed using a standardised examination protocol. Anticoagulant therapy was withheld from patients with negative findings on compression ultrasound, and 1,254 of them were randomly selected for follow-up. The main outcome measure was the three-month incidence of symptomatic venous thromboembolic events confirmed by objective testing. DVT was detected in 1,023 patients (26.4%), including 454 (11.7%) and 569 (14.7%) cases of proximal and isolated distal DVT, respectively. Of the 1,254 patients with negative results sampled for follow-up, six received anticoagulant therapy during follow-up and five were lost to follow-up. Five of 1,243 patients (0.4%, 95% confidence interval [CI], 0.1-0.9) experienced non-fatal symptomatic venous thromboembolic events (pulmonary embolism in two patients and DVT in three patients) and eight of 1,254 patients (0.6%, 95% CI, 0.3-1.2) died during the three-month follow-up. In conclusion, anticoagulant therapy can be safely withheld after negative complete compression ultrasound without further testing in the ambulatory office setting

Inappropriate dispatcher decision for emergency medical service users with acute myocardial infarction.

International audienceOBJECTIVES: Current guidelines recommend utilization of prehospital emergency medical services (EMSs) by patients with ST-elevation myocardial infarction (STEMI). The aims of this study were to estimate the percentage of inappropriate initial dispatcher decisions and determine their impact on delays in reperfusion therapy for EMS users with STEMI. METHODS: As part of a prospective regional registry of patients with STEMI, we analyzed the original data for 245 patients who called a university hospital-affiliated EMS call center in France. The primary study outcome was time to reperfusion therapy calculated from the documented date and time of the first patient call. RESULTS: The initial EMS dispatcher's decision was appropriate (ie, dispatching a mobile intensive care unit staffed by an emergency or critical care physician) for 171 (70%) patients and inappropriate for 74 (30%) patients. Inappropriate decisions included referring the patient to a family physician (n = 59), providing medical advice (n = 9), and dispatching an ambulance (n = 6). Inappropriate initial decisions resulted in increased median time to reperfusion for 140 patients receiving fibrinolysis (95 vs 53 minutes; P < .001) and 91 patients undergoing primary percutaneous coronary intervention (170 vs 107 minutes; P < .001). In-hospital mortality was not different between the 2 study groups (6.8% vs 9.9%; P = .42). CONCLUSION: The initial dispatcher's decision is inappropriate for 30% of EMS users with STEMI and results in substantial delays in time to reperfusion therapy. Accuracy of telephone triage should be improved for patients who activate EMSs in response to symptoms suggestive of acute coronary syndrome