Laura McDonald

Real-world data in the United Kingdom: opportunities and challenges

Real-world data is that collected outside the constraints of controlled clinical trials and is increasingly informing decision-making in healthcare. The landscape of real-world data in the United Kingdom is set to evolve over the coming months as the government plans to build on databases currently in place by collecting patient data from all family practices and linking this information with hospital records. This initiative, called care.data, has the potential to be an invaluable resource. However, the programme has been criticized on grounds of data privacy, which has led to an extended delay in its implementation and the expectation that a large number of people will opt out. Opt-outs may introduce substantial biases to the dataset, and understanding how to account for these presents a significant challenge for researchers. For the scope and quality of real-world evidence in the United Kingdom to be realised, and for this information to be used effectively, it is essential to address this challenge.

A review of data sharing statements in observational studies published in the BMJ: A cross-sectional study

In order to understand the current state of data sharing in observational research studies, we reviewed data sharing statements of observational studies published in a general medical journal, the British Medical Journal. We found that the majority (63%) of observational studies published between 2015 and 2017 included a statement that implied that data used in the study could not be shared. If the findings of our exploratory study are confirmed, room for improvement in the sharing of real-world or observational research data exists.

Lack of data sharing in observational studies

Several articles call for the sharing of clinical trial data,12 but sharing observational data receives little—and arguably insufficient—attention. This is despite the important uses of these data, for example in assessing the weekend effect in the UK3 and in national clinical guidelines.4 …

Performing studies using the UK Clinical Practice Research Datalink: to link or not to link?

The Clinical Practice Research Datalink (CPRD) is a repository of electronic medical records collected during routine primary care clinical practice in the UK, and is one of the most widely used sources of real-world data for healthcare research. Although CPRD provides access to comprehensive longitudinal patient records, the data does not fully capture diagnoses or outcomes occurring in secondary care and/or mortality. We provide here an overview of CPRD and the potential bias when using unlinked data in certain situations. Linkage of CPRD to other datasets can help to overcome these limitations. We discuss when to consider linkage to secondary care, disease-specific data sources or the official mortality data when conducting research using CPRD data.

An analysis of characteristics of post-authorisation studies registered on the ENCePP EU PAS Register

Background: The objective of this study was to investigate the study design characteristics of Post-Authorisation Studies (PAS) requested by the European Medicines Agency which were recorded on the European Union (EU) PAS Register held by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Methods: We undertook a cross-sectional descriptive analysis of all studies registered on the EU PAS Register as of 18 th October 2016. Results: We identified a total of 314 studies on the EU PAS Register, including 81 (26%) finalised, 160 (51%) ongoing and 73 (23%) planned. Of those studies identified, 205 (65%) included risk assessment in their scope, 133 (42%) included drug utilisation and 94 (30%) included effectiveness evaluation. Just over half of the studies (175; 56%) used primary data capture, 135 (43%) used secondary data and 4 (1%) used a hybrid design combining both approaches. Risk assessment and effectiveness studies were more likely to use primary data capture (60% and 85% respectively as compared to 39% and 14% respectively for secondary). The converse was true for drug utilisation studies where 59% were secondary vs. 39% for primary. For type 2 diabetes mellitus, database studies were more commonly used (80% vs 3% chart review, 3% hybrid and 13% primary data capture study designs) whereas for studies in oncology, primary data capture were more likely to be used (85% vs 4% chart review, and 11% database study designs). Conclusions: Results of this analysis show that PAS design varies according to study objectives and therapeutic area.

Real-world data really matter

We read with interest the editorial by Morin and Flegel highlighting the benefits that a Canadian national health care data network could provide.[1][1] National patient registers from Nordic countries provide clear examples of the advantages of having access to data on a country-wide level.[2][2]

Evolving landscape of stroke prevention in atrial fibrillation within the UK between 2012 and 2016: a cross-sectional analysis study using CPRD

Objective To describe the changes in prescribing of oral anticoagulant (AC) and antiplatelet (AP) agents in patients with non-valvular atrial fibrillation (NVAF) in the UK and to identify the characteristics associated with deviation from guideline-based recommendations. Design Five cross-sectional analyses in a large retrospective population-based cohort study. Setting General practices contributing data to the UK Clinical Practice Research Datalink. Participants The study included patients with a diagnosis of NVAF and eligible for anticoagulation (CHA2DS2-VASc score ≥2) on 1 April of 2012, 2013, 2014, 2015 and 1st January 2016. Results The proportion of patients being treated with AC increased at each index date, showing an absolute rise of 16.7% over the study period. At the same time, the proportion of patients treated with an AP alone was reduced by half, showing an absolute decrease of 16.8%. The proportion of patients not receiving any antithrombotic (AT) treatment remained the same across the study period. A number of predictors were identified for AP alone or no treatment compared with AC treatment. Conclusion Major improvements in the AT management of patients with NVAF for stroke prevention in the UK were observed between April 2012 and January 2016. Despite this, nearly 20% of at-risk patients still received AP alone and over 15% were on no AT agents in January 2016.

Google searches do not correlate with melanoma incidence in majority English speaking countries

Recent reports have suggested that internet search behaviour may be a valuable tool to estimate melanoma incidence and mortality. Previous studies have used incorrect statistical methods, were focussed on the United States and/or did not use non-cancer control search terms to provide a context for interpreting the effects seen with the cancer-related terms. Using more robust statistical methods we found that no cancer search terms were significantly, or strongly correlated with melanoma incidence in 6 countries.

Evaluation of comparative effectiveness research: a practical tool

Comparative effectiveness research (CER) guidelines have been developed to direct the field toward the most rigorous study methodologies. A challenge, however, is how to ensure the best evidence is generated, and how to translate methodologically complex or nuanced CER findings into usable medical evidence. To reach that goal, it is important that both researchers and end users of CER output become knowledgeable about the elements that impact the quality and interpretability of CER. This paper distilled guidance on CER into a practical tool to assist both researchers and nonexperts with the critical review and interpretation of CER, with a focus on issues particularly relevant to CER in oncology.

Time to really share real-world data?

Data other than that from clinical trials are important for healthcare decision making. However, unlike the vocal calls seen for more open access to trial data, there are limited efforts being made to ensure that agencies that collect real-world data (RWD) share this, despite its importance. There are many RWD sources across the world that could be readily exploited for research once shared. There are policy and privacy questions that need to be tackled, but opening up and sharing RWD offers remarkable potential for improvements in care for individuals and more effective use of limited healthcare resources. Open science should become the standard for RWD as well as clinical trials, especially those that have a high likelihood to influence practice.