Distributed Queries for Quality Control Checks in Clinical Trials

Operational Quality Control (QC) checks are standard practice in clinical trials and ensure ongoing compliance with the study protocol, standard operating procedures (SOPs) and Good Clinical Practice (GCP). We present a method for defining QC checks as distributed queries over case report forms (CRF) and clinical imaging data- sources. Our distributed query system can integrate time-sensitive information in order to populate QC checks that can facilitate discrepancy resolution workflow in clinical trials

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)

AbstractEfficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM’s initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements.Using a case study approach, we evaluated ODM’s ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard

Leptospirosis Surveillance System Readiness in the Banyumas District (A Case Study in the Banyumas District Using a Qualitative Approach, 2015)

Leptospirosis is a newly emerging infectious disease in Indonesia’s Banyumas District. Based on data provided by the District Health Office (DHO) in Banyumas, there were 22 cases of leptospirosis between 2010 and May 2014. Leptospirosis surveillance is crucial for the prevention and control of the disease. The aim of this study was to achieve an in-depth understanding of leptospirosis surveillance system readiness in the Banyumas District. The research used qualitative methods, and all research data were collected using purposive techniques to examine eight informants via in-depth interviews, observations, and document studies. The datawere subject to content analysis. The results showed that input readiness does support the system, but it is inadequate, while overall process readiness was not good enough, and the output was suboptimal. The main supporting factors for this study were the availability of resources, awareness, good communication and research partners/cooperation. The main inhibiting factors were the incomplete nature of the data infrastructure, especially the limited availability of Rapid Diagnstic Tests (RDT) and surveillance case report forms, the lack of reporting agreements, and the lack of evaluating standards. Improvement in and the development of a system with proper budget allocations is required for the availability of microscopic agglutination test (MAT) and polymerase chain reaction (PCR) in hospitals, the development of standard operating procedures (SOP) for the leptospirosis surveillance system, surveillance case report forms, the distribution of RDT at public health centers, and the activation of surveillance based at the community level. With this in mind, it is expected that the DHO Banyumas will create and distribute surveillance case report forms and follow SOP, in order for the leptospirosis surveillance system in Banyumas to be sustainedand systematic. Keywords: System, Surveillance, Leptospirosi

Correction: Life and bladder cancer: protocol for a longitudinal and cross-sectional patient-reported outcomes study of Yorkshire (UK) patients

© Author(s) (or their employer(s)) 2019. This article was previously published with an error in figures. The correct figures are below: Figure 1: Study data flow for the longitudinal study (workstream 2). NCRAS, National Cancer Registration and Analysis. (Figure Presented). Figure 2: Study data flow for the cross-sectional study (workstream 3). CRFs, case report forms; PHE, Public Health England; PIS, patient information sheet. (Figure Presented)

A methodological framework for assessing agreement between cost-effectiveness outcomes estimated using alternative sources of data on treatment costs and effects for trial-based economic evaluations

A new methodological framework for assessing agreement between cost-effectiveness endpoints generated using alternative sources of data on treatment costs and effects for trial-based economic evaluations is proposed. The framework can be used to validate cost-effectiveness endpoints generated from routine data sources when comparable data is available directly from trial case report forms or from another source. We illustrate application of the framework using data from a recent trial-based economic evaluation of the probiotic Bifidobacterium breve strain BBG administered to babies less than 31 weeks of gestation. Cost-effectiveness endpoints are compared using two sources of information; trial case report forms and data extracted from the National Neonatal Research Database (NNRD), a clinical database created through collaborative efforts of UK neonatal services. Focusing on mean incremental net benefits at £30,000 per episode of sepsis averted, the study revealed no evidence of discrepancy between the data sources (two-sided p values >0.4), low probability estimates of miscoverage (ranging from 0.039 to 0.060) and concordance correlation coefficients greater than 0.86. We conclude that the NNRD could potentially serve as a reliable source of data for future trial-based economic evaluations of neonatal interventions. We also discuss the potential implications of increasing opportunity to utilize routinely available data for the conduct of trial-based economic evaluations

A methodological framework for assessing agreement between cost-effectiveness outcomes estimated using alternative sources of data on treatment costs and effects for trial-based economic evaluations

A new methodological framework for assessing agreement between cost-effectiveness endpoints generated using alternative sources of data on treatment costs and effects for trial-based economic evaluations is proposed. The framework can be used to validate cost-effectiveness endpoints generated from routine data sources when comparable data is available directly from trial case report forms or from another source. We illustrate application of the framework using data from a recent trial-based economic evaluation of the probiotic Bifidobacterium breve strain BBG administered to babies less than 31 weeks of gestation. Cost-effectiveness endpoints are compared using two sources of information; trial case report forms and data extracted from the National Neonatal Research Database (NNRD), a clinical database created through collaborative efforts of UK neonatal services. Focusing on mean incremental net benefits at £30,000 per episode of sepsis averted, the study revealed no evidence of discrepancy between the data sources (two-sided p values >0.4), low probability estimates of miscoverage (ranging from 0.039 to 0.060) and concordance correlation coefficients greater than 0.86. We conclude that the NNRD could potentially serve as a reliable source of data for future trial-based economic evaluations of neonatal interventions. We also discuss the potential implications of increasing opportunity to utilize routinely available data for the conduct of trial-based economic evaluations

Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D Feasibility) : a randomised feasibility trial protocol

The SUpport through Mobile Messaging and digital health Technology for Diabetes research team acknowledge the support of the National Institute for Health Research (NIHR) through the Clinical Research Networks (AF: NIHR Senior Investigator and AF and RR: funding from NIHR Oxford Biomedical Research Consortium). All trial data will be entered on electronic case report forms. The clinical database is built on Research Electronic Data Capture, a secure, web-based application designed to support data capture for research studiesPeer reviewedPublisher PD

Study protocol: The DOse REsponse Multicentre International collaborative initiative (DO-RE-MI)

INTRODUCTION: Current practices for renal replacement therapy in intensive care units (ICUs) remain poorly defined. The DOse REsponse Multicentre International collaborative initiative (DO-RE-MI) will address the issue of how the different modes of renal replacement therapy are currently chosen and performed. Here, we describe the study protocol, which was approved by the Scientific and Steering Committees. METHODS: DO-RE-MI is an observational, multicentre study conducted in ICUs. The primary end-point will be the delivered dose of dialysis, which will be compared with ICU mortality, 28-day mortality, hospital mortality, ICU length of stay and number of days of mechanical ventilation. The secondary end-point will be the haemodynamic response to renal replacement therapy, expressed as percentage reduction in noradrenaline (norepinephrine) requirement. Based on the the sample analysis calculation, at least 162 patients must be recruited. Anonymized patient data will be entered online in electronic case report forms and uploaded to an internet website. Each participating centre will have 2 months to become acquainted with the electronic case report forms. After this period official recruitment will begin. Patient data belong to the respective centre, which may use the database for its own needs. However, all centres have agreed to participate in a joint effort to achieve the sample size needed for statistical analysis. CONCLUSION: The study will hopefully help to collect useful information on the current practice of renal replacement therapy in ICUs. It will also provide a centre-based collection of data that will be useful for monitoring all aspects of extracorporeal support, such as incidence, frequency, and duration