Evaluation of completeness of adverse drug reaction case reports published in biomedical Journals: A preliminary analysis

Lund

Munn

et al. 2021

Introduction: Without a robust evidence base to support recommendations for medical services at mass gatherings (MGs), levels of care will continue to vary and preventable morbidity and mortality will exist. Accordingly, researchers and clinicians publish case reports and case series to capture and explain some of the health interventions, health outcomes, and host community impacts of MGs. Streamlining and standardizing post-event reporting for MG medical services and associated health outcomes could improve inter-event comparability, thereby supporting and promoting growth of the evidence base for this discipline. The present paper is focused on theory building, proposing a set of domains for data that may support increasingly comprehensive, yet lean, reporting on the health outcomes of MGs. This paper is paired with another presenting a proposal for a post-event reporting template. Methods: The conceptual categories of data presented are based on a textual analysis of 54 published post-event medical case reports and a comparison of the features of published data models for MG health outcomes. Findings: A comparison of existing data models illustrates that none of the models are explicitly informed by a conceptual lens. Based on an analysis of the literature reviewed, four data domains emerged. These included: (i) the Event Domain, (ii) the Hazard and Risk Domain, (iii) the Capacity Domain, and (iv) the Clinical Domain. These domains mapped to 16 sub-domains. Discussion: Data modelling for the health outcomes related to MGs is currently in its infancy. The proposed illustration is a set of operationally relevant data domains that apply equally to small, medium, and large-sized events. Further development of these domains could move the MG community forward and shift post-event health outcomes reporting in the direction of increasing consistency and comprehensiveness. Conclusion: Currently, data collection and analysis related to understanding health outcomes arising from MGs is not informed by robust conceptual models. This paper is part of a series of nested papers focused on the future state of post-event medical reporting.

Section: Standardizing the Collection Of Essential Data Pointsmentioning

confidence: 99%

Measuring the Masses: Domains Driving Data Collection and Analysis for the Health Outcomes of Mass Gatherings (Paper 3)

Lund

Munn

et al. 2021

Measuring the Masses: The Current State of Mass-Gathering Medical Case Reporting (Paper 1)

Rabb

Munn

et al. 2021

Introduction: Case reports are commonly used to report the health outcomes of mass gatherings (MGs), and many published reports of MGs demonstrate substantial heterogeneity of included descriptors. As such, it is challenging to perform rigorous comparisons of health services and outcomes between similar and dissimilar events. The degree of variation in published reports has not yet been investigated. Objective: Examine patterns of post-event medical reporting in the existing literature and identify inconsistencies in reporting. Methods: A systematic review of case reports was conducted. Included were English studies, published between January 2009 and December 2018, in Prehospital and Disaster Medicine (PDM) or Current Sports Medicine Reports (CSMR). Analysis of each paper was used to develop a list of 27 categories of data. Results: Seventy-five studies were initially reviewed with 54 publications meeting the inclusion criteria. Forty-two were full case reports (78%) and 12 were conference proceedings (22%). Of the 27 categories of data studied, only 13 were consistently reported in more than 50% of publications. Reporting patterns included inconsistent use of terminology/language and variable retrievability of reports. Reporting on event descriptors, hazard and risk analysis, and clinical outcomes were also inconsistent. Discussion: Case reports are essential tools for researchers and event team members such as medical directors and event producers. The authors found that current case reports, in addition to being inconsistent in content, were generally descriptive rather than explanatory; that is, focused on describing the outcomes as opposed to exploring possible connections between context and health outcomes. Conclusion: This paper quantifies and demonstrates the current state of heterogeneity in MG event reporting. This heterogeneity is a significant impediment to the functional use of published reports to further the science of MG planning and to improve health outcomes. Future work based on the insights gained from this analysis will aim to align and standardize reporting to improve the quality and value of event reporting.

Measuring the Masses: A Proposed Template for Post-Event Medical Reporting (Paper 4)

Rabb

Chasmar

et al. 2021

Background: Standardizing and systematizing the reporting of health outcomes from mass gatherings (MGs) will improve the quality of data being reported. Setting minimum standards for case reporting is an important strategy for improving data quality. This paper is one of a series of papers focused on understanding the current state, and shaping the future state, of post-event case reporting. Methods: Multiple data sources were used in creating a lean, yet comprehensive list of essential reporting fields, including a: (1) literature synthesis drawn from analysis of 54 post-event case reports; (2) comparison of existing data models for MGs; (3) qualitative analysis of gaps in current case reports; and (4) set of data domains developed based on the preceding sources. Findings: Existing literature fails to consistently report variables that may be essential for not only describing the health outcomes of a given event, but also for explaining those outcomes. In the context of current and future state reporting, 25 essential variables were identified. The essential variables were organized according to four domains, including: (i) Event Domain; (ii) Hazard and Risk Domain; (iii) Capacity Domain; and (iv) Clinical Domain. Discussion: The authors propose a first-generation template for post-event medical reporting. This template standardizes the reporting of 25 essential variables. An accompanying data dictionary provides background and standardization for each of the essential variables. Of note, this template is lean and will develop over time, with input from the international MG community. In the future, additional groups of variables may be helpful as “overlays,” depending on the event category and type. Conclusions: This paper presents a template for post-event medical reporting. It is hoped that consistent reporting of essential variables will improve both data collection and the ability to make comparisons between events so that the science underpinning MG health can continue to advance.