Pilot study of a European oncology regimen reference library and matching algorithm.

OBJECTIVES: As yet, there is no European data standard for naming and describing oncology regimens. To enable real-world cancer treatment data comparisons, the Oncology Data Network created a unified reference database for systemic anti-cancer regimens used in practice across Europe. Data are extracted from clinical systems and mapped to a single standard called the "Core Regimen Reference Library (CRRL)". An automated matching algorithm has been designed based on: drug combinations; administration schedule; and dosing and route of administration. Incomplete matches are flagged for expert review. The aim of this pilot study is to have an expert pharmacist panel test the algorithm's feasibility by comparing computerised and manual matching of regimens that are currently in use in different European countries. METHODS: The combined team pooled a diverse sample of 47 reference regimens used in Europe for solid and haematological cancers. These were then codified to the developed common data standard and the algorithm was used to match them to the CRRL. The expert pharmacist panel from the European Society of Oncology Pharmacy (ESOP) selected 12 regimens from the sample set, ranging from simple to complex, and performed a single-blind test of the algorithm, by systematically matching each original regimen to the CRRL. RESULTS: ESOP validated the algorithm's feasibility based on full concurrence between manual and computer matches thereby validating the algorithm rules and logic with regard to what defines the core characteristics of a regimen and how to compare similarities and differences. CONCLUSIONS: ESOP's validation of the matching algorithm and approach to curating a master library provides confidence in their utility for reliable comparison of real-world regimen usage across Europe.

Real-world evidence research based on big data: Motivation-challenges-success factors.

BACKGROUND: In recent years there has been an increasing, partially also critical interest in understanding the potential benefits of generating real-world evidence (RWE) in medicine. OBJECTIVES: The benefits and limitations of RWE in the context of randomized controlled trials (RCTs) are described along with a view on how they may complement each other as partners in the generation of evidence for clinical oncology. Moreover, challenges and success factors in building an effective RWE network of cooperating cancer centers are analyzed and discussed. MATERIAL AND METHODS: This article is based on a selective literature search (predominantly 2015-2017) combined with our practical experience to date in establishing European oncology RWE networks. RESULTS: RWE studies can be highly valuable and complementary to RCTs due to their high external validity. If cancer centers successfully address the various challenges in the establishment of an effective RWE study network and in the consequent execution of studies, they may efficiently generate high-quality research findings on treatment effectiveness and safety. Concerns pertaining to data privacy are of utmost importance and discussed accordingly. Securing data completeness, accuracy, and a common data structure on routinely collected disease and treatment-related data of patients with cancer is a challenging task that requires high engagement of all participants in the process. CONCLUSION: Based on the discussed prerequisites, the analysis of comprehensive and complex real-world data in the context of a RWE study network represents an important and promising complementary partner to RCTs. This enables research into the general quality of cancer care and can permit comparative effectiveness studies across partner centers. Moreover, it will provide insights into a broader optimization of cancer care, refined therapeutic strategies for patient subgroups as well as avenues for further research in oncology.

The complex causes of delays in A&E.

An extremely busy 48-h period in our Accident and Emergency (A&E) department prompted a close examination of clinical decision making. Decisions that were made both at the time of attendance at A&E and during the patients' subsequent hospital stay were gathered from patient records and the patient information system. A number of vignettes are presented to illustrate our findings. The brief case reviews provide a range of alternative explanations for the delays and prolongation of patient stays, aside from the often-cited 'shortage of capacity'. Amongst the key difficulties that were identified were poor communication between clinicians and hospital teams, a lack of co-ordination in respect to assessment and care of patients and admissions to hospital for patients who could quite safely be treated in primary care settings. Data are also presented on the high number of different locations that patients were moved to within the hospital along with contextual information. All findings are discussed in the context of clinical decision making and the allocation of a fixed 'hospital resource'. A number of specific suggestions are made for the improvement of both the local A&E system and more broad suggestions are made for clinicians in other A&E departments to consider.