The Value of Medical Registries and Observational Studies Early in Pandemics: The Coronavirus Disease 2019 (COVID-19) Experience.

Whereas randomized clinical trials remain the gold standard for evaluating new therapies for infections, we argue that registries and observational studies early in the coronavirus disease 2019 (COVID-19) pandemic provided invaluable understanding of the natural history and preliminary data on risk factors and possible treatments. We review the data from the current pandemic, the history of registries in general, and their value in public health emergencies. Lessons from these experiences should be incorporated into rigorous planning for the next pandemic.

The effect of treatment and clinical course during Emergency Department stay on severity scoring and predicted mortality risk in Intensive Care patients.

BACKGROUND: Treatment and the clinical course during Emergency Department (ED) stay before Intensive Care Unit (ICU) admission may affect predicted mortality risk calculated by the Acute Physiology and Chronic Health Evaluation (APACHE)-IV, causing lead-time bias. As a result, comparing standardized mortality ratios (SMRs) among hospitals may be difficult if they differ in the location where initial stabilization takes place. The aim of this study was to assess to what extent predicted mortality risk would be affected if the APACHE-IV score was recalculated with the initial physiological variables from the ED. Secondly, to evaluate whether ED Length of Stay (LOS) was associated with a change (delta) in these APACHE-IV scores. METHODS: An observational multicenter cohort study including ICU patients admitted from the ED. Data from two Dutch quality registries were linked: the Netherlands Emergency department Evaluation Database (NEED) and the National Intensive Care Evaluation (NICE) registry. The ICU APACHE-IV, predicted mortality, and SMR based on data of the first 24 h of ICU admission were compared with an ED APACHE-IV model, using the most deviating physiological variables from the ED or ICU. RESULTS: A total of 1398 patients were included. The predicted mortality from the ICU APACHE-IV (median 0.10; IQR 0.03-0.30) was significantly lower compared to the ED APACHE-IV model (median 0.13; 0.04-0.36; p < 0.01). The SMR changed from 0.63 (95%CI 0.54-0.72) to 0.55 (95%CI 0.47-0.63) based on ED APACHE-IV. Predicted mortality risk changed more than 5% in 321 (23.2%) patients by using the ED APACHE-IV. ED LOS > 3.9 h was associated with a slight increase in delta APACHE-IV of 1.6 (95% CI 0.4-2.8) compared to ED LOS < 1.7 h. CONCLUSION: Predicted mortality risks and SMRs calculated by the APACHE IV scores are not directly comparable in patients admitted from the ED if hospitals differ in their policy to stabilize patients in the ED before ICU admission. Future research should focus on developing models to adjust for these differences.

A multifactorial regression analysis of the features of community-acquired rotavirus requiring hospitalization in Spain as represented in the Minimum Basic Data Set.

Over 10% of acute rotavirus gastroenteritis (ARGE) requires hospitalization because of complications. The aggravating factors have been widely analysed, but in an isolated way. We aimed to explore the interrelationship between the clinical and epidemiological factors that characterize rotavirus hospitalizations in Spain using information from the Minimum Basic Data Set (MBDS). Using ICD-9-CM codes, we classified acute gastroenteritis (AGE) cases by principal diagnosis fields and then categorized their comorbidities, complications, and epidemiological features by secondary fields. A multivariable, logistic, step-wise regression model was then constructed. We identified 1657 ARGE cases from 17 415 cases of AGE. Rotavirus hospitalizations were associated with place of residence, age, and season (P < 0·0001), as well as with dehydration [odds ratio (OR) 12·44, 95% confidence interval (CI) 1·52-40·38], intravenous rehydration (OR 1·74, 95% CI 1·29-2·35), metabolic acidosis (OR 1·51, 95% CI 1·24-1·83), respiratory tract infections (RTIs) (OR 1·60, 95% CI 1·09-1·98), and concomitant AGE (OR 1·52, 95% CI 1·03-2·25). Dehydration was four times more likely in patients aged <5 years (OR 4·36, 95% CI 1·20-12·96) and was associated with acidosis when ARGE and RTI were present simultaneously (P < 0·0001). Specific co-infecting viruses may play a role in acute respiratory symptoms and aggravation of gastrointestinal manifestations of rotaviruses, thus leading to complications requiring hospitalization.

First steps toward understanding the variability in acute pain service provision and the quality of pain relief in everyday practice across the United Kingdom.

BACKGROUND: Pain management for patients in hospital is a major problem. There is significant variation in care provision. Evidence is needed about the ways in which acute pain services are organized in order to understand whether these are linked to important differences in patient outcomes. The National Inpatient Pain Study group is a voluntary collaborative venture of inpatient pain specialists in the United Kingdom who are working toward establishing a national prospective database of service provision and activity. OBJECTIVES: The objectives of this article are (1) to describe current pain service provision and activity (2) to define and monitor the quality and side effects of the primary analgesic techniques, such as central neuraxial block or systemic analgesia, and identify variations in practice. METHODS: Phase 1: Surveys were conducted in two phases during 2010-2011. Information about the organization of services was collected from 121 centers via a live Website. Phase 2: The pilot clinical dataset was collected from 13 hospitals in 2011. RESULTS: Results indicated that staffing varied widely from one to nine nurses per hospital site. Twelve percent of hospitals did not routinely collect data. The main workload was orthopedic and general surgery based on data from 13 hospitals and 29,080 patients in 2011. Thirty-seven percent of patients reported a pain score of moderate to severe pain on the first assessment by the specialist pain team, and 21% reported severe pain. Nausea and vomiting was the most frequent adverse event reported. Sixty-nine major adverse events were logged, of which 64 documented respiratory depression (N = 29,080, 0.22%). CONCLUSIONS: Prospective longitudinal data has the potential to improve our understanding of variation in process and outcome measures and establish future research priorities.

Developing a Policy and Procedure Framework and Manual for a National Comprehensive Implantable Medical Device Registry in Saudi Arabia.

Policy and procedure manuals provide guidance on the operation and governance of medical device registries. In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) has been developing and implementing a comprehensive national registry for implantable medical devices to facilitate the monitoring of device outcomes through post-market surveillance studies. To help guide the operations of this registry, the SFDA developed a policy and procedure manual. This paper reports on the design of the framework used to develop that manual over the course of one year (2015-2016), using a variety of literature sources, and working with medical device registry and health systems experts. The policy and procedure manual included five key principal level categories, which led to the subsequent creation of seven policies and 28 relevant procedures. The five principal categories were: Staff Engagement, Information Governance, Quality and Auditing, Research, and Reporting. The results of this work could be used to guide the development of policies and procedures for other implantable medical device registries.

Building a cloud-based data sharing model for the Saudi national registry for implantable medical devices: Results of a readiness assessment.

BACKGROUND: Implantable medical device registries are used as a medium to conduct post-marketing surveillance. Little information is available on the development and implementation of implantable biomedical device registries in general and specifically in Saudi Arabia and the Middle East. OBJECTIVES: This study presents the experiences of building an implantable medical device registry in the Kingdom of Saudi Arabia. The work specifically addresses the early experiences of the Saudi Food and Drug Authority in the planning and development of a data sharing model for the implementation of a medical device registry at different hospital sites within the country. METHODS: A two-year case study in which 60 health professionals from 5 hospitals in Saudi Arabia participated in a readiness assessment survey. The readiness assessment examined system-level capacity, hospital workflow and operations, clinical staff-level engagement, and technological assessment as they relate to the implementation of the Implantable Medical Device Registry (IMDR). Both subjective and objective data were collected as part of the readiness assessment survey at each hospital site. Data was collected from participants either individually or as part of a group at each hospital site. Using Microsoft Excel, Microsoft Word, flip charts, and back-and-forth discussion, the data was descriptively summarized and synthesized to provide an overview of hospital readiness for IMDR implementation. RESULTS: Results show that there are large differences among Saudi hospitals in terms of their readiness for IMDR implementation due to a variety of factors relating to differences in hospital-wide organizational systems, clinical practice, technological infrastructure, and data sharing capabilities. Each of the hospitals surveyed in this study had differences in how clinical biomedical implantation policies and procedures were utilized. Manual entry into the cloud-based IMDR was recommended as the most optimal data sharing model that would mitigate the differences between hospital readiness for IMDR implementation. CONCLUSION: Registries play a major role in monitoring the effectiveness of implantable biomedical devices. National standardized policies, enforced regulations, and information technology infrastructure are needed to achieve this goal. Furthermore, due to differences in hospital readiness, building a cloud-based registry system through manual data entry into the IMDR was found to be the most appropriate data sharing model that can be implemented at the national level.

Registro de trauma: uma necessidade nos prontos-socorros do Brasil / Trauma registry: a necessity for Brazilian trauma centers

O trauma constitui-se em importante problema de saúde pública no Brasil, figurando entre as três primeiras causas de morte. O registro de trauma fornece informações úteis capazes de melhorar o atendimento às vítimas, definir medidas de prevenção, fornecer informações para aplicação de recursos e possibilitar fonte de dados para pesquisas científicas. O processo de implementação dos registros de trauma em hospitais não é dispendioso. Utiliza softwares específicos para obtenção de informações preestabelecidas das vítimas. A implementação desses registros nos prontos-socorros é também essencial para a integração de banco de dados de trauma em níveis estaduais e nacional.

Trauma is an important problem in the Brazilian public health system, appearing among the three first causes of death. The trauma registry provides useful information able to improve the victim's assistance, to define preventative measures, provide information for resources application and make possible a data source for scientific researches. The implementation process of trauma registry in hospitals isn't expensive. It uses specific softwares for getting the victims' pre-settled information. These registries implementation in the emergency rooms is also essential for the integration of trauma data banks at national and state levels