Reference set for performance testing of pediatric vaccine safety signal detection methods and systems

BackgroundSafety signal detection in spontaneous reporting system databases and electronic healthcare records is key to detection of previously unknown adverse events following immunization. Various statistical methods for signal detection in these different datasources have been developed, however none are geared to the pediatric population and none specifically to vaccines. A reference set comprising pediatric vaccine-adverse event pairs is required for reliable performance testing of statistical methods within and across data sources.MethodsThe study was conducted within the context of the Global Research in Paediatrics (GRiP) project, as part of the seventh framework programme (FP7) of the European Commission. Criteria for the selection of vaccines considered in the reference set were routine and global use in the pediatric population. Adverse events were primarily selected based on importance. Outcome based systematic literature searches were performed for all identified vaccine-adverse event pairs and complemented by expert committee reports, evidence based decision support systems (e.g. Micromedex), and summaries of product characteristics. Classification into positive (PC) and negative control (NC) pairs was performed by two independent reviewers according to a pre-defined algorithm and discussed for consensus in case of disagreement.ResultsWe selected 13 vaccines and 14 adverse events to be included in the reference set. From a total of 182 vaccine-adverse event pairs, we classified 18 as PC, 113 as NC and 51 as unclassifiable. Most classifications (91) were based on literature review, 45 were based on expert committee reports, and for 46 vaccine-adverse event pairs, an underlying pathomechanism was not plausible classifying the association as NC.ConclusionA reference set of vaccine-adverse event pairs was developed. We propose its use for comparing signal detection methods and systems in the pediatric population.     

分诊安全管理结合风险管理提高急诊科护理质量评分的作用分析

目的探讨分诊安全管理结合风险管理提高急诊科护理质量评分的作用。方法该院于2018年6月起加强对急诊科的分诊安全管理结合风险管理,以于2017年6月—2019年6月在该院急诊科就诊的患者为研究对象,评价管理策略实施前后护理风险发生率、护理质量评分以及患者满意度等评价指标变化情况。结果实施后基础护理、实践操作、消毒隔离、急救药品、护理文件方面的护理质量评分均较实施前显著提高(P<0.05);实施后护理差错、护理缺陷、护理投诉的发生率分别为0.26%、0.58%、0.19%,均较实施前显著降低(P<0.05);实施后护理总满意率为94.92%,较实施前显著提高(P<0.05)。结论分诊安全管理结合风险管理有效提高了急诊科护理质量,提升了患者满意度,减少了护理风险事件的发生。     

Effect of a Simple Exercise Program on Hospitalization-Associated Disability in Older Patients: A Randomized Controlled Trial

ObjectiveHospitalization-associated disability [HAD, ie, the loss of ability to perform ≥1 basic activities of daily living (ADLs) independently at discharge] is a frequent condition among older patients. The present study assessed whether a simple inpatient exercise program decreases HAD incidence in acutely hospitalized very old patients.DesignIn this randomized controlled trial (Activity in Geriatric Acute Care) participants were assigned to a control or intervention group and were assessed at baseline, admission, discharge, and 3 months thereafter.Setting and ParticipantsIn total, 268 patients (mean age 88 years, range 75–102) admitted to an acute care for older patients unit of a public hospital were randomized to a control (n = 125) or intervention (exercise) group (n = 143).MethodsBoth groups received usual care, and patients in the intervention group also performed simple supervised exercises (walking and rising from a chair, for a total duration of ∼20 minutes/day). We measured ADL function (Katz index) and incident HAD at discharge and after 3 months (primary outcome) and Short Physical Performance Battery, ambulatory capacity, number of falls, rehospitalization, and death during a 3-month follow-up (secondary outcomes).ResultsMedian duration of hospitalization was 7 days (interquartile range 4 days). The intervention group had a lower risk of HAD with reference to both baseline [odds ratio (OR) 0.36; 95% confidence interval (CI) 0.17–0.76, P = .007] and admission (OR 0.29; 95% CI 0.10–0.89, P = .030). A trend toward an improved ADL function at discharge vs admission was found in the intervention group compared with controls (OR 0.32; 95% CI ‒0.04 to 0.68; P = .083). No between-group differences were noted for the other endpoints (all P > .05).Conclusion and ImplicationsA simple inpatient exercise program decreases risk of HAD in acutely hospitalized, very old patients.     

The role of National Immunization Technical Advisory Groups (NITAG) in strengthening health system governance: Lessons from three middle-income countries—Argentina,Jordan, and South Africa (2017–2018)

IntroductionToward the Global Vaccine Action Plan 2020 goal, almost 90% of countries have established a National Immunization Technical Advisory Group (NITAG). However, little is known about NITAG's contributions to governance.MethodsIn 2017–2018, a two-step, qualitative retrospective study was conducted. Jordan (JO), Argentina (AR), and South Africa (SA) were selected owing to government-financed NITAGs from middle-income countries (MICs), geographic diversity, and a vaccine introduction with NITAG support. Country case studies were developed, collecting data through desk review and face-to-face key informant interviews (KIIs) from Ministry of Health (MoH) and NITAG. Case studies were analyzed together, to assess governance applying the European Observatory on Health Systems and Policies framework focusing on transparency, accountability, participation, integrity, and policy capacity (TAPIC).ResultsDocument review and 53 KII (22 AR, 20 SA, 11 JO) showed NITAGs played a pivotal role as advisors promoting a culture of evidence-informed policies. NITAGs strengthened governance, although practices varied among countries. Meetings were conducted behind-closed-doors, participation restricted to members, only in one country agendas, and recommendations were public (AR). To increase participation, policy capacity, and transparency, countries considered adding experts in communications, advocacy, and economics. AR and SA contemplated including community members. NITAGs functioned autonomously from the government, with no established internal or external monitoring or supervision. NITAG meeting minutes allowed the review of integrity, adherence to terms of reference, standard operating procedures, and conflict of interest (CoI). For the most part, NITAGs abided by their mandates. Significant issues were related to the level of MoH support and oversight of CoI declaration and documentation.ConclusionsSystematically implementing governance approaches could improve processes, better tailor policies, and implementation. The long-term survival and resilience of NITAGs in these countries showed they play a significant role in strengthening governance. Lessons learned could be useful to those promoting country-driven evidence-informed decision-making.     

Endoscopy-Related Bleeding and Thromboembolic Events in Patients on Direct Oral Anticoagulants or Vitamin K Antagonists

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¿Es el intervalo libre de docetaxel un factor predictivo para el cáncer de próstata resistente a la castración?

ObjectiveProstate cancer (PCa) is the second most common solid tumor in men and the fifth leading cause of cancer-related death. In advanced stage, palliative treatments are used instead of curative therapies. Therefore, finding predictive indicators seems crucial. Patients with castration-resistant prostate cancer (CRPC) that received Dx chemotherapy have been retrospectively reviewed. The aim of this study was to investigate whether docetaxel (Dx)-free interval could have a predictive value for PCa and influence other sequential therapies.Material and methodsThis clinical trial study was performed on 104 patients at Medeniyet University Oncology Clinic in 2018-2020. All CRPC patients had metastases, received Dx as first-line treatment and underwent androgen receptor axis targeted (ARAT) therapy after disease progression. We analyzed patients’ progression time after Dx therapy and the effects on sequential treatment.ResultsAfter Dx therapy, all patients received ARAT (abiraterone (ABI) n: 49 (47.1%) and enzalutamide (ENZ) n: 54 (51.9%)) as a second-line treatment, except for one patient who received cabazitaxel. There was a statistically significant relationship between the Dx-free interval and duration of response to ARAT (P<.001). The response time of ARAT treatment was <10.5 months in all patients whose Dx-free interval period was <9 months.ConclusionsOur findings support the theory that Dx-free interval can be a predictive factor for CRPC. CRPC disease can be classified as Dx-sensitive disease or Dx-resistance disease, based on the Dx-free interval. Decision on subsequent treatments could be made considering this information.