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Evidence‐informed or evidence‐based practice refers to “the conscientious, explicit, and judicious use of current, best evidence in making decisions about the care of individual patients” (Sackett et al., 1997, p. 2). Proponents of evidence‐based practice believe that interventions, evaluated in the context of research studies and found effective and safe, can be delivered in the same and consistent manner to produce the same effects in clients presenting with the same health problem, under the conditions of day‐to‐day practice. They advocate the development of guidelines to inform practice. Guidelines consist of systematically developed statements about recommendations for interventions that have demonstrated effectiveness and can be used to address a health problem, and procedures for monitoring the intervention's outcomes. The guidelines are disseminated to health professionals who are expected to implement the recommended interventions (Fernandez et al., 2015).

Proponents of evidence‐based practice developed a hierarchy of research designs that are most appropriate for generating evidence on the effectiveness of interventions. They place high value on evidence derived from primary or meta‐analytic studies that used the RCT design to investigate the effects of interventions. The RCT is deemed the most reliable, even the “gold standard” for intervention evaluation research because its features are believed to minimize potential biases. Controlling for biases is required for demonstrating the causal effects of the intervention on outcomes (Hansen & Tjørnhøj‐Thomsen, 2016; Holm et al., 2017).

To date, experiences with evidence‐based practice have been less than optimal. It is estimated that up to 55% of clients receive interventions recommended in guidelines for acute, chronic, and preventive healthcare, and if provided, wide variations in implementing the evidence‐based interventions were observed (Greenhalgh et al., 2014; Harris et al., 2017). Several factors related to the characteristics of the healthcare system, organization, health professionals, clients, and the interventions affect the implementation of evidence‐based interventions and guidelines in daily practice (Lau et al., 2016). Evidence suggests that health professionals do not depend on research as a source of information to guide practice. Rather, they rely on other sources, primarily clinical knowledge either gained personally or shared by colleagues, as well as client experience (Spenceley et al., 2008).

Recently, concerns have been raised about the applicability of evidence, derived from primary and meta‐analytic studies using the RCT design, in informing practice (Ioannidis, 2016). Overall, the concerns stem from limitations of the RCT design in generating evidence that is relevant to the practice context (Braithwaite et al., 2018; Reeve et al., 2016). The limitations are related to the features of the RCT (i.e. careful selection of participants, random assignment, standardized delivery of treatment) that enable the focus on the direct causal effects of an intervention on outcomes and the control of potential sources of bias. As such, the RCT features ignore the complexity of the real world, the individuality of clients' experiences of the health problem and life circumstances as well as responses to treatment, and clients' participation in treatment decisions.

Careful selection of participants confines the RCT sample to a select subgroup of the target client population (e.g. clients with no comorbid conditions), which limits the applicability of the findings to other subgroups of clients seen in practice (Greenhalgh et al., 2014). Random assignment of participants to treatment groups does not reflect the treatment decision‐making process followed in practice. Therefore, random assignment is not well received by clients participating in the RCT (thereafter referred to as participants) and has been found to affect enrollment in the trial, attrition and nonadherence to treatment, which weaken the validity of inferences regarding the effectiveness of an intervention (see Chapter 14). Standardized delivery of interventions is not responsive to clients' individual experiences, life circumstances, and preferences. Standardization also is difficult to transport into practice due to the complex and inter‐related influence of factors pertaining to clients, health professionals, and context (Chu & Leino, 2017; Leask et al., 2019). The focus on the average direct causal effects of the intervention ignores individual variability in clients' responses to treatment (i.e. level of improvement in outcomes observed following treatment completion) and the mechanism through which the treatment produces its benefits; yet, health professionals need to understand what client subgroups respond favorably to the intervention and how the intervention produces its benefits for making appropriate treatment decisions (Horwitz et al., 2017; Lipsitz & Markowitz, 2013; Van Belle et al., 2016).

The limitations extend to meta‐analytic studies or systematic reviews of RCT findings, which form the basis for recommendations stated in guidelines. Attempts at synthesizing RCT‐derived evidence face challenges associated with limited replication (e.g. Pereira & Ioannidis, 2011). Limited replication is manifested in conflicting and, therefore, inconclusive evidence of the intervention's effectiveness (Hesselink et al., 2014). Accordingly, the guidelines' recommendations are usually stated in general terms that simply identify the interventions that can be used in addressing a health problem (Edwards et al., 2007). In addition, reports of primary and meta‐analytic studies as well as guidelines provide a brief description of the interventions. Insufficient description of the interventions constrains their replication and proper implementation in research and practice (Bach‐Mortensen et al., 2018; Levinton, 2017). For instance, Glasziou et al. (2010) found that health professionals were able to replicate the interventions evaluated in half of 80 studies published in the journal of Evidence‐Based Medicine. Furthermore, the guidelines do not offer instructions on how to adapt the design and delivery of interventions in a way that preserves their active ingredients yet is responsive to the characteristics, preferences, and life circumstances of clients and to the resources available in local practice contexts (Bach‐Mortensen et al., 2018; Westfall et al., 2009).

Accordingly, the evidence generated in primary and meta‐analytic studies using the RCT design is of limited utility in informing practice. It does not address the questions that health professionals ask when making treatment decisions (Bonell et al., 2018; Levinton, 2017). The questions include:

 Who (i.e. clients with what sociodemographic and health or clinical profiles) most benefit (i.e. demonstrate improvement in outcomes) from an intervention, delivered in what mode and at what dose?

 What are the intervention's active ingredients (operationalized in what specific components) responsible for its benefits?

 What risks or discomforts are associated with the intervention?

 How and why does the intervention work to produce its benefits? Or, what is the mechanism of action responsible for the intervention's effectiveness in addressing the health problem?

 What resources are needed to deliver the intervention?

 What contextual factors influence the delivery of the intervention by health professionals, its uptake and enactment by clients, and its effectiveness?

 To what extent and how can the intervention be tailored to the individual clients' characteristics or preferences, and/or adapted to the local practice context?

 What alternative interventions are available to address the health problem, and what are their relative benefits (effectiveness) and risks (safety)?

Intervention research needs to be reoriented toward developing well‐conceptualized yet practice‐relevant interventions, and generating the evidence that addresses these questions. The goal is to consolidate the theoretical and empirical knowledge that informs practice, and ultimately improves the quality of healthcare and the health of clients. To be useful in informing practice, intervention research should embrace a realist, pragmatic perspective in reflecting the characteristics of practice: client‐centeredness and complexity. This can be achieved through client engagement and use of a range of relevant research designs and methods.