Good practices for clinical data warehouse implementation: a case study in France

Real World Data (RWD) bears great promises to improve the quality of care. However, specific infrastructures and methodologies are required to derive robust knowledge and brings innovations to the patient. Drawing upon the national case study of the 32 French regional and university hospitals governance, we highlight key aspects of modern Clinical Data Warehouses (CDWs): governance, transparency, types of data, data reuse, technical tools, documentation and data quality control processes. Semi-structured interviews as well as a review of reported studies on French CDWs were conducted in a semi-structured manner from March to November 2022. Out of 32 regional and university hospitals in France, 14 have a CDW in production, 5 are experimenting, 5 have a prospective CDW project, 8 did not have any CDW project at the time of writing. The implementation of CDW in France dates from 2011 and accelerated in the late 2020. From this case study, we draw some general guidelines for CDWs. The actual orientation of CDWs towards research requires efforts in governance stabilization, standardization of data schema and development in data quality and data documentation. Particular attention must be paid to the sustainability of the warehouse teams and to the multi-level governance. The transparency of the studies and the tools of transformation of the data must improve to allow successful multi-centric data reuses as well as innovations in routine care.Comment: 16 page

Governance in health care delivery : raising performance

The impacts of health care investments in developing and transition countries are typically measured by inputs and general health outcomes. Missing from the health agenda are measures of performance that reflect whether health systems are meeting their objectives; public resources are being used appropriately; and the priorities of governments are being implemented. This paper suggests that good governance is central to raising performance in health care delivery. Crucial to high performance are standards, information, incentives and accountability. This paper provides a definition of good governance in health and a framework for thinking about governance issues as a way of improving performance in the health sector. Performance indicators that offer the potential for tracking relative health performance are proposed, and provide the context for the discussion of good governance in health service delivery in the areas of budget and resource management, individual provider performance, health facility performance, informal payments, and corruption perceptions. What we do and do not know about effective solutions to advance good governance and performance in health is presented for each area, drawing on existing research and documented experiences.Health Monitoring&Evaluation,Health Systems Development&Reform,Public Sector Expenditure Policy,Health Economics&Finance,Health Law

EXPLORING STRUCTURAL AND SYSTEMIC IMPROVEMENTS TO PROMOTE EFFECTIVE AND EFFICIENT PHARMACEUTICAL SUPPLY CHAIN MANAGEMENT FOR HIV/AIDS SERVICE DELIVERY IN NIGERIA

ABSTRACT Ibegbunam, Innocent Ndubuisi: Exploring structural and systemic improvements to promote effective and efficient pharmaceutical supply chain management for HIV/AIDS service delivery in Nigeria (Under the direction of Pam Silberman) The uninterrupted availability of health products is essential for the provision of HIV/AIDS services. A 2015 assessment of public health supply chain systems in Nigeria supporting HIV/AIDS services revealed that some vital HIV/AIDS products were unavailable in about 9%–16% of health facilities visited. This implied >10% of the health facilities visited did not have all the life-saving HIV/AIDS commodities needed to provide needed clinical services. Health commodity unavailability interrupts health service delivery, negatively affects the quality of services and adversely affects patient adherence to treatment. This suggests a need for changes in the HIV/AIDS supply chain management (SCM) system. The aim of this study was to explore structural and systemic improvements needed to promote effective and efficient public-sector pharmaceutical SCM system for HIV/AIDS service delivery in Nigeria through (I) identification of current gaps in the pharmaceutical SCM system (II) identification of potential solutions to address the gaps (III) exploring effective solutions in Nigeria and other places, and (IV) identification of policy improvements for the pharmaceutical SCM system. The study was conducted using sequential mixed-method design of surveys and key informant interviews. The results identified poor logistics data management and use, poor information dissemination for decision-making, limited leadership and funding, poor performance management and limited human resources capacity to support SCM services which disrupts HIV/AIDS service delivery. Some of the solutions to address these gaps include: use of electronic systems for logistics data management to enhance decision-making, more widespread dissemination of information on changes in clinical guidelines and the SCM system, improvements in government leadership and funding, establishment of an accountability structure, improved performance management of private sector contracted to support the supply chain system, and improved human resource management. In addition, the study identified the need to set policies on minimum remaining shelf-life requirements for donated health products, minimum levels of government funding to support the supply chain system, and an implementation plan for the national supply chain policy.Doctor of Public Healt

The Assessment of Technology Adoption Interventions and Outcome Achievement Related to the Use of a Clinical Research Data Warehouse

Introduction: While funding for research has declined since 2004, the need for rapid, innovative, and lifesaving clinical and translational research has never been greater due to the rise in chronic health conditions, which have resulted in lower life expectancy and higher rates of mortality and adverse outcomes. Finding effective diagnostic and treatment methods to address the complex challenges in individual and population health will require a team science approach, creating the need for multidisciplinary collaboration among practitioners and researchers. To address this need, the National Institutes of Health (NIH) created the Clinical and Translational Science Awards (CTSA) program. The CTSA program distributes funds to a national network of medical research institutions, known as “hubs,” that work together to improve the translational research process. With this funding, each hub is required to achieve specific goals to support clinical and translational research teams by providing a variety of services, including cutting edge use of informatics technologies. As a result, the majority of CTSA recipients have implemented and maintain data warehouses, which combine disparate data types from a range of clinical and administrative sources, include data from multiple institutions, and support a variety of workflows. These data warehouses provide comprehensive sets of data that extend beyond the contents of a single EHR system and provide more valuable information for translational research. Although significant research has been conducted related to this technology, gaps exist regarding research team adoption of data warehouses. As a result, more information is needed to understand how data warehouses are adopted and what outcomes are achieved when using them. Specifically, this study focuses on three gaps: research team awareness of data warehouses, the outcomes of data warehouse training for research teams, and how to measure objectively outcomes achieved after training. By assessing and measuring data warehouse use, this study aims to provide a greater understanding of data warehouse adoption and the outcomes achieved. With this understanding, the most effective and efficient development, implementation, and maintenance strategies can be used to increase the return on investment for these resource-intensive technologies. In addition, technologies can be better designed to ensure they are meeting the needs of clinical and translational science in the 21st century and beyond. Methods: During the study period, presentations were held to raise awareness of data warehouse technology. In addition, training sessions were provided that focused on the use of data warehouses for research projects. To assess the impact of the presentations and training sessions, pre- and post-assessments gauged knowledge and likelihood to use the technology. As objective measurements, the number of data warehouse access and training requests were obtained, and audit trails were reviewed to assess trainee activities within the data warehouse. Finally, trainees completed a 30-day post-training assessment to provide information about barriers and benefits of the technology. Results: Key study findings suggest that the awareness presentations and training were successful in increasing research team knowledge of data warehouses and likelihood to use this technology, but did not result in a subsequent increase in access or training requests within the study period. In addition, 24% of trainees completed the associated data warehouse activities to achieve their intended outcomes within 30 days of training. The time needed for adopting the technology, the ease of use of data warehouses, the types of support available, and the data available within the data warehouse may all be factors influencing this completion rate. Conclusion: The key finding of this study is that data warehouse awareness presentations and training sessions are insufficient to result in research team adoption of the technology within a three-month study period. Several important implications can be drawn from this finding. First, the timeline for technology adoption requires further investigation, although it is likely longer than 90 days. Future assessments of technology adoption should include an individual’s timeline for pursuing the use of that technology. Second, this study provided a definition for outcome achievement, which was completion o

Charting the Legal Environment of Health Information

Over the past several years, increased attention has been focused on the importance of health information to health care quality improvement. The level of focus on health information has increased with the advent of electronic medical records and electronic health information systems designed to facilitate the use of health care data. Although these systems are still in their relative infancy, they hold enormous promise for revolutionizing the availability and use of health information to improve clinical performance, empower employers and consumers to better understand health plan choices and facilitate health claims administration. Their potential has been a catalyst for change in a growing number of communities, with the emergence of private/public partnerships to develop regional health information systems

Improving the Accuracy of Publicly Reported PSI Rates through Enhanced Internal Documentation Review

Patient Safety Indicators, or PSIs, are used by several healthcare related federal agencies and third-party payers to determine the quality of care being delivered by a healthcare provider. A composite PSI, PSI-90, includes a group of PSIs that are publicly reported as quality indicators for a provider, and that are used as part of the Value Based Purchasing calculation. Poor PSI-90 rates directly influence healthcare services reimbursement rates by CMS and may be considered an indication of a quality of care problem by potential patients and third party payers. This research is a case study on the effectiveness of a program implemented by the Medical University of South Carolina (MUHA) to improve the accuracy of their reported PSI-90 composite score

Research integrity in randomized clinical trials: A scoping umbrella review

Background: Randomized clinical trials (RCTs) are experiencing a crisis of confidence in their trustworthiness. Although a comprehensive literature search yielded several reviews on RCT integrity, an overarching overview is lacking. Objectives: The authors undertook a scoping umbrella review of the research integ- rity literature concerning RCTs. Search strategy and selection criteria: Following prospective registration (https:// osf.io/3ursn), two reviewers independently searched PubMed, Scopus, The Cochrane Library, and Google Scholar, without language or time restrictions, until November 2021. The authors included systematic reviews covering any aspect of research integ- rity throughout the RCT lifecycle. Data collection and analysis: The authors assessed methodological quality using a modified AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews) tool and collated the main findings. Main results: A total of 55 relevant reviews, summarizing 6001 studies (median per review, 63; range, 8–1106) from 1964 to 2021, had an overall critically low quality of 96% (53 reviews). Topics covered included general aspects (15%), design and approval (22%), conduct and monitoring (11%), reporting (38%), postpublication concerns (2%), and future research (13%). The most common integrity issues covered were ethics (18%) and transparency (18%). Conclusions: Low-quality reviews identified various integrity issues across the RCT lifecycle, emphasizing the importance of high ethical standards and professional- ism while highlighting gaps in the integrity landscape. Multistakeholder consensus is needed to develop specific RCT integrity standards.Spanish GovernmentResearch institute Carlos III CM20/00074Universidad de Granada/CBU

Applying the theory of constraints to the logistics service of medical records of a hospital

Management of patient records in a hospital is of major importance, for its impact both on the quality of care and on the associated costs. Since this process is circular, the prevention of the building up of bottlenecks is especially important. Thus, the objective of this paper was to analyze whether the Theory of Constraints (TOC) can be useful to the logistics of medical records in hospitals. The paper is based on a case study conducted about the 2007-2011 period in the Medical Records Logistics Service at the Hospital Universitario Virgen Macarena in Seville (Spain). From April 2008, a set of actions in the clinical record logistics system were implemented based on the application of TOC principles. The results obtained show a significant increase in the level of service and employee productivity, as well as a reduction of cost and the number of patients’ complaints