Studying Deprescribing Using Routinely Collected Healthcare Data: Old Challenges and New Opportunities

IF 3.3 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Jonas W. Wastesson, Karl-Hermann Sielinou Kamgang, Carina Lundby, Anton Pottegård
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引用次数: 0

Abstract

In routinely collected healthcare data, deprescribing is in most cases indistinguishable from drug discontinuation. This is not a minor technical challenge; it is a fundamental limitation in most routinely collected data sources, such as dispensing data, electronic health records and registries. Deprescribing is only a subset of discontinuation, defined by its intentionality, clinical supervision and patient perspective: ‘Deprescribing is the process of withdrawal of an inappropriate medication, supervised by a healthcare professional with the goal of managing polypharmacy and improving outcomes’ [1]. Supervision by clinicians and goal-setting with patients are defining features, yet they remain invisible in routinely collected data. Any attempt to identify deprescribing without acknowledging this constraint risks conflating clinical decision-making with other reasons for discontinuation such as patient adherence issues. This paper reflects on how creative use of routinely collected data may nevertheless further our understanding of the impact of deprescribing and, on occasion, allow distinguishing deprescribing from other forms of discontinuation.

There is a need for observational studies in deprescribing research. Large-scale deprescribing trials are unlikely, as most trials depend on pharmaceutical industry funding and deprescribing lacks commercial incentive. Hence, registry studies (routinely collected administrative health care data) remain one of the few options for studying deprescribing at scale [2]. Although this function is constrained by the inability to distinguish deprescribing from other forms of discontinuation in routinely collected data, creative use of data and design can overcome some challenges.

We acknowledge calls for stricter conceptual clarity in the use of the term deprescribing, emphasizing shared decision-making and structured follow-up [3]. This definition is typically achievable in intervention studies. However, in pharmacoepidemiologic research, such detailed process elements are rarely observable. If conceptual criteria were applied rigidly, most register-based studies would be excluded from deprescribing research. We take a more pragmatic view. When the aim is to study deprescribing, even without full access to process details, it is reasonable to use the term, provided the operational definition is clearly stated and its limitations acknowledged. This allows the research to stay conceptually focused while contributing to the broader evidence base.

The challenges of identifying deprescribing are not new to the field of pharmacoepidemiology and can be summarized as below.

The key challenges of identifying deprescribing should not discourage researchers from studying this in routinely collected data. Rather, we argue that careful use of data can move the deprescribing field forward.

An alternative to the approach of enriching data is to find examples where the bias from exposure misclassification and confounding is less prevalent.

Medication management systems can reduce exposure misclassification. An example of this comes from Sweden's ApoDos system where patients receive pre-sorted, time-stamped medication pouches every 2 weeks. As prescriptions are renewed regularly, primary non-adherence is nearly impossible, and secondary non-adherence is restricted to selective pill omission. This means that when a drug is not renewed, the decision has most certainly been made in consultation with a physician, making this a robust setting for studying deprescribing in real-world data. Medication management systems with similar features that reduce the risk of non-adherence and irregular filling patterns are also used in some US nursing homes [10]. Using such data is likely to limit exposure misclassification but does not reduce confounding by indication and can reduce generalizability.

Medication shortages, that is, where a drug is temporarily unavailable, can be used as natural experiments in pharmacoepidemiological studies [11]. In deprescribing research, medication shortages could provide causal effect estimates, where the confounding effect of the indication/reason for deprescribing is removed. However, it should be noted that drug shortages are often handled by switching to alternative treatments, which makes it harder to find realistic opportunities for deprescribing researchers.

Deprescribing remains difficult to study in routinely collected data, mainly because it cannot be reliably distinguished from other forms of discontinuation unless explicitly recorded. This limitation is fundamental but should not be paralysing. Register studies are essential for generating large-scale real-world evidence on deprescribing. By combining prescribing data with care events, using structured settings like multidose systems and refining prescriber and patient-level signals, we can improve identification. Until deprescribing is routinely documented, our best option is to triangulate intent from patterns. This is not a workaround, but a necessary foundation for studying deprescribing at scale.

The authors declare no conflicts of interest.

Abstract Image

使用常规收集的医疗数据研究处方处方:旧挑战和新机遇。
在常规收集的医疗保健数据中,在大多数情况下,开处方与停药难以区分。这不是一个小的技术挑战;这是大多数常规收集数据源(如配药数据、电子健康记录和注册表)的基本限制。开处方只是停药的一个子集,由其意向性、临床监督和患者观点来定义:“开处方是在医疗保健专业人员的监督下,以管理多种药物和改善结果为目标,停药的过程。”临床医生的监督和患者的目标设定是明确的特征,但它们在常规收集的数据中仍然是不可见的。任何试图在不承认这一限制的情况下确定处方,都有可能将临床决策与其他停药原因(如患者依从性问题)混为一谈。本文反映了如何创造性地使用常规收集的数据,尽管如此,可能会进一步加深我们对处方解除的影响的理解,有时,允许区分处方解除与其他形式的停药。在处方研究中有必要进行观察性研究。大规模的处方减少试验不太可能,因为大多数试验依赖于制药工业的资助,而处方减少缺乏商业激励。因此,注册研究(常规收集的行政卫生保健数据)仍然是研究bbb规模处方的少数选择之一。虽然由于无法区分常规收集数据中的处方和其他形式的中断,这一功能受到限制,但创造性地使用数据和设计可以克服一些挑战。我们认识到要求在使用“说明”一词时更加明确概念,强调共同决策和有组织的后续行动。这一定义通常在干预研究中可以实现。然而,在药物流行病学研究中,这种详细的过程元素很少被观察到。如果严格应用概念标准,大多数基于登记的研究将被排除在描述性研究之外。我们采取更务实的观点。当目的是研究描述时,即使没有完全访问过程细节,只要明确说明了操作定义并承认其局限性,使用该术语也是合理的。这使得研究在为更广泛的证据基础做出贡献的同时,在概念上保持专注。在药物流行病学领域,识别处方的挑战并不新鲜,可以总结如下。识别处方的关键挑战不应阻碍研究人员在常规收集的数据中进行研究。相反,我们认为仔细使用数据可以推动描述领域向前发展。丰富数据的另一种方法是找到曝光错误分类和混淆造成的偏差不那么普遍的例子。药物管理系统可以减少暴露错误分类。瑞典的ApoDos系统就是一个例子,患者每两周就会收到预先分类的、带有时间戳的药物袋。由于处方定期更新,原发性不依从几乎是不可能的,而继发性不依从仅限于选择性遗漏药丸。这意味着,当一种药物不更新时,几乎肯定是在与医生协商后做出的决定,这为研究现实世界数据中的处方处方提供了一个强有力的环境。一些美国养老院也使用了具有类似功能的药物管理系统,可以减少不依从性和不规则填充模式的风险。使用这些数据可能会限制暴露错误分类,但不能减少指征的混淆,并可能降低普遍性。药物短缺,即药物暂时无法获得的情况,可以用作药物流行病学研究中的自然实验[b]。在开处方研究中,药物短缺可以提供因果效应估计,其中取消了开处方的适应症/原因的混淆效应。然而,应该指出的是,药物短缺通常是通过转向其他治疗方法来解决的,这使得开处方的研究人员更难以找到现实的机会。在常规收集的数据中研究处方解除仍然很困难,主要是因为除非明确记录,否则无法可靠地将其与其他形式的停药区分开来。这种限制是根本的,但不应使其瘫痪。登记研究对于产生关于处方的大规模真实证据至关重要。通过将处方数据与护理事件结合起来,使用多剂量系统等结构化设置,并改进处方者和患者层面的信号,我们可以提高识别能力。在描述被常规记录下来之前,我们最好的选择是从模式中对意图进行三角测量。 这不是权宜之计,而是大规模研究处方的必要基础。作者声明无利益冲突。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
5.60
自引率
6.50%
发文量
126
审稿时长
1 months
期刊介绍: Basic & Clinical Pharmacology and Toxicology is an independent journal, publishing original scientific research in all fields of toxicology, basic and clinical pharmacology. This includes experimental animal pharmacology and toxicology and molecular (-genetic), biochemical and cellular pharmacology and toxicology. It also includes all aspects of clinical pharmacology: pharmacokinetics, pharmacodynamics, therapeutic drug monitoring, drug/drug interactions, pharmacogenetics/-genomics, pharmacoepidemiology, pharmacovigilance, pharmacoeconomics, randomized controlled clinical trials and rational pharmacotherapy. For all compounds used in the studies, the chemical constitution and composition should be known, also for natural compounds.
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