June
Issue
19 34 Padma Gulur:
Cybersecurity Page 20
Adam Arthur:
Profile
Page 19
Page 14
Big data set to increase the efficiency of stroke outcomes research A topical review published in Stroke investigates new approaches for the collection of outcomes data after stroke. In the context of global technological growth, the authors, David Ung, Monique F Kilkenny (senior author), Monash University colleagues (Melbourne, Australia) and international colleagues from the USA and Canada, propose: “Continued advancements in streamlining data linkage, without compromising privacy, will not only lead to an explosive increase in the use of data linkage for stroke outcomes research, but will also fill research gaps as we work towards understanding other patient groups.” They further conclude: “These real-world data offer a promising opportunity for evaluations to improve evidence-based practice and policy decision-making.”
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he authors acknowledge that currently “the quality of outcomes data such as mortality, adverse events, and disability can vary by type and timing of the collected data, such as the inhospital, short-term and long-term periods”. Proposing that there are three primary strategies for collecting outcomes data after stroke: clinical studies, clinical stroke registries, and administrative data, the authors weigh up their advantages and shortcomings against the utility of linking datasets. For example, while Ung et al suggest that administrative databases were not designed for research or clinical purposes, they propose that such databases “reflect real-world practice, are large and comprehensive, population-based, have potentially indefinite follow-up, and are less expensive and resource intensive than clinical studies”. However, the authors also allude to their limitations, the primary one concerning selection biases. “Selection biases can make it difficult to appropriately define the population, [as] patients with better access to healthcare or who present with more severe and non-fatal symptoms may be more likely to be captured.” Furthermore, Ung and colleagues speculate that these databases may include inaccurate or incomplete data that may not encompass the entire population. They also add: “Another limitation arises when codes that lead to greater reimbursement of funds to hospitals are favoured over the principal
Continued advancements [...] will also fill research gaps as we work towards understanding other patient groups.”
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Latest FDA caution for the use of off-label drugs in intrathecal drug delivery systems deemed “inconsistent with current practice”
While the US Food and Drug Administration (FDA) has called for caution regarding the use of off-label medications administered intrathecally, pain management experts have come together and, in a letter to the editor of Neuromodulation, call for an addendum to the communication due to its “inconsistency with current practice”. “USE CAUTION WITH implanted pumps for intrathecal administration of medicines for pain management,” reported the recent FDA safety communication. With the action aiming to improve safety, it was intended for patients who have an implanted pump, as well as caregivers and healthcare providers. Several physician leaders feel this caution needs more clarification, including Timothy Deer (The Spine and Nerve Center of the Virginias, Charleston,
USA) and Philip Kim (Center for Interventional Pain Spine, Bryn Mawr, USA), among an array of pain treatment experts. “We are concerned that this FDA alert may have the unintentional action of inappropriately limiting our ability to offer treatments within the standard of care for our chronic intractable pain patients,” write principal authors Deer and Kim. While Deer and colleagues say they agree with the FDA’s goal of improving safety and reducing risks, they put forward that general use of off-label medications has been an ongoing practice standard for many years and suggest that the safety communication “will have a detrimental impact on many patients and on the practice of medicine in the USA and potentially abroad”. According to manufacturer registry data highlighted in the letter, over 80% of patients treated for chronic pain of a noncancerous origin receive drugs that Continued on page 19