Nursing and Health Interventions. Souraya Sidani
1.4.4 Examination of Contextual Factors
Interventions, complex or not, are delivered in real‐world context. The context includes the practice setting in which health professionals provide the interventions, and the environment in which clients apply the treatment recommendations. In either case, context is complex, characterized by variability on a multitude of factors, occurring at different levels (Chandler et al., 2016; Masterson‐Algar et al., 2018) and at different points in time (Cambon et al., 2019). The factors are embedded within the physical, psycho‐socio‐cultural, economic, and political setting or environment, and encountered at the micro (e.g. individual, home), meso (e.g. workplace, organization), or macro (e.g. healthcare system) levels. Contextual factors influence the implementation and the effectiveness of interventions (Craig et al., 2018). It, therefore, is essential to account for context in the design and evaluation of interventions. This can be achieved by: (1) engaging various stakeholder groups (e.g. clients, health professionals, decision‐makers) in the design and adaptation of interventions (Braithwaite et al., 2018; Greenwood‐Lee et al., 2016)—the groups are knowledgeable of the local context and provide valuable feedback on what factors are operating in that context, how to address the factors, and how to modify the intervention to enhance its fit with the features and resources available at the local context; and (2) incorporating a process evaluation within an intervention evaluation study (see Chapter 13) aimed to monitor the implementation of the intervention, examine its mechanism of action, and exploring if and how contextual factors affect interventions' implementation and effectiveness (Moore et al., 2019). The findings of a process evaluation are critical for the validity of a study's conclusions; specifically, they point to factors that contributed, positively or negatively, to the interventions' effects.
1.4.5 Examination of Client Individuality
Individuality of clients adds to the complexity of real‐world practice. In addition to their experience of co‐occurring health problems, clients vary in their sociodemographic and health profiles, and most importantly differ in their beliefs about health in general and the presenting health problem such as possible causes of the problem. These beliefs influence clients' health behaviors and shape their preferences for treatment (De las Cuevas et al., 2018). Respecting their beliefs and accounting for their preferences are principles of client‐centered care that are gaining wide interest in intervention research. This is evident in: (1) calls to determine the social acceptability, in addition to clinical effectiveness and economic efficiency, of interventions (Staniszewska et al., 2010), and to design tailored interventions that customize interventions to individual clients' characteristics and preferences (Radhakrishan, 2012); and (2) widening recognition of the utility of pragmatic and preference trials for evaluating interventions. Clients also differ in their response to interventions: some experience improvement in the health problem, whereas others show no change or even deterioration. The latter subgroups of clients may require modification of their treatment, also referred to as adaptive interventions. The modification or adaptation may include a range of possibilities such as intensifying the interventions (e.g. increasing its dose) or providing different ones (e.g. stepped‐up care) based on their responses (Hekler et al., 2018). Advances in health technology are facilitating the design and delivery of adaptive interventions, and innovative research designs are proposed to evaluate them. Planned subgroup analysis can be applied to determine the profiles of clients who most benefit from the intervention.
1.5 CLIENT ENGAGEMENT IN INTERVENTION RESEARCH
The high value placed on client‐centered care and the less‐than‐optimal implementation of evidence‐based interventions by health professionals, and uptake and enactment by clients, served as the impetus for engaging clients in intervention research. Client engagement takes place in different stages and steps of research:
1 Identifying research priorities for funding agencies (e.g. Patient‐Centered Outcomes Research Institute in the US), most pressing health needs of the general public, or services requiring improvement in a healthcare organization or system: The James Lind Alliance has developed a systematic process for engaging clients (e.g. persons experiencing a health problem, health professionals) in identifying research priorities (Cowan, 2010; Manafò et al., 2018).
2 Setting the research questions to be addressed in a study: Clients join the research team as collaborators. They actively participate in stating the study aims, and may assist in preparing or reviewing the grant proposal prior to submission.
3 Designing new interventions, co‐creating or co‐producing the intervention protocol and materials (Hwakins et al., 2017; Kildea et al., 2019), selecting and adapting evidence‐based interventions (Aarons et al., 2012; Sidani et al., 2017): This involves a systematic process in which clients serve as consultants or as participants in a research study aimed to adapt or co‐create interventions.
4 Delineating the study protocol: As collaborators, clients have experiential knowledge that is useful in determining: the target populations' acceptance of randomization and of methods for data collection; effective sources and strategies for recruitment; convenient locations for delivering the interventions; and suitability (comprehension, readability, response burden) of measures to a range of participants.
5 Recruiting participants, facilitating data collection, and assisting in the interpretation and dissemination of findings: Clients serving as collaborators or participants in a study can assume these responsibilities.
Client engagement in intervention research may reduce research waste. Client involvement is expected to: (1) identify research questions relevant to research or evidence users including clients or the general public, health professionals, and decision‐makers (Ioannidis, 2016; McLeod et al., 2014); (2) yield interventions that are optimally designed (Bleijenberg et al., 2018) and acceptable to users, which is likely to improve their uptake in practice; and (3) enhance participants' enrollment and retention, thereby reducing the resources, cost, and time needed to complete the study.
1.6 ADVANCES IN INTERVENTION RESEARCH METHODS
The increasing demand for addressing questions of relevance to practice (Chavez‐MacGregor & Giordano, 2016; Concato et al., 2010) and mounting evidence dispelling misconceptions about the strengths of the RCT and the weaknesses of non‐RCT or observation designs (Frieden, 2017) have brought to the forefront the importance of the research questions or aims in informing the selection of research designs and methods in intervention research (Skivington et al., 2018). Accordingly, researchers have a more inclusive range of research designs and methods to choose from. Designs considered appropriate for evaluating health interventions are presented in several publications (e.g. Medical Research Council guidance, 2019; Shadish et al., 2002; Sidani, 2015). The main categories of designs and methods are described in Chapters 14 and 15, respectively. The overall trend is toward embracing a pragmatic, realist approach to intervention evaluation research that is conducted within the context of practice and reflects the complexity of inter‐relations among client, health professional and contextual factors, intervention implementation, and outcomes. Practical trials, preference trials, adaptive designs, and multiple or mixed‐methods designs are relevant methodological innovations. The selection of a research design should be informed by the research questions, taking into consideration feasibility, ethical and safety issues (Lobo et al., 2017).
1.7 PROCESS FOR DESIGNING, EVALUATING, AND IMPLEMENTING INTERVENTIONS
The process for designing, evaluating, and implementing interventions is systematic and rigorous, yet flexible and iterative (Czajkowski et al., 2015; Medical Research Council, 2019). It involves phases that are logically sequenced. Although some may be conducted simultaneously, the results of each phase drive the work forward toward the next phase or backward