Complex Interventions in Health
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Complex Interventions in Health

An overview of research methods

David A. Richards, Ingalill Rahm Hallberg, David A. Richards, Ingalill Rahm Hallberg

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eBook - ePub

Complex Interventions in Health

An overview of research methods

David A. Richards, Ingalill Rahm Hallberg, David A. Richards, Ingalill Rahm Hallberg

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About This Book

Health and human services currently face a series of challenges – such as aging populations, chronic diseases and new endemics – that require highly complex responses, and take place in multiple care environments including acute medicine, chronic care facilities and the community. Accordingly, most modern health care interventions are now seen as 'complex interventions' – activities that contain a number of component parts with the potential for interactions between them which, when applied to the intended target population, produce a range of possible and variable outcomes. This in turn requires methodological developments that also take into account changing values and attitudes related to the situation of patients' receiving health care.

The first book to place complex interventions within a coherent system of research enquiry, this work is designed to help researchers understand the research processes involved at each stage of developing, testing, evaluating and implementing complex interventions, and assist them to integrate methodological activities to produce secure, evidence-based health care interventions. It begins with conceptual chapters which set out the complex interventions framework, discuss the interrelation between knowledge development and evidence, and explore how mixed methods research contributes to improved health. Structured around the influential UK Medical Research Council guidance for use of complex interventions, four sections, each comprised of bite-sized chapters written by multidisciplinary experts in the area, focus on:

- Developing complex interventions

- Assessing the feasibility of complex interventions and piloting them

- Evaluating complex interventions

- Implementing complex interventions.

Accessible to students and researchers grappling with complex interventions, each substantive chapter includes an introduction, bulleted learning objectives, clinical examples, a summary and further reading. The perspectives of various stakeholders, including patients, families and professionals, are discussed throughout as are the economic and ethical implications of methods.

A vital companion for health research, this book is suitable for readers from multidisciplinary disciplines such as medical, nursing, public health, health services research, human services and allied healthcare backgrounds.

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Publisher
Routledge
Year
2015
ISBN
9781134470563
Edition
1
1
THE COMPLEX INTERVENTIONS FRAMEWORK
David A. Richards
In the year 2000, the Medical Research Council (MRC) in the United Kingdom (UK) published a document that aimed to guide researchers on how to investigate the effects of health care interventions that could be regarded as complex (Medical Research Council, 2000). Whilst this document was found extremely useful by many researchers internationally, it was superseded in 2008 by a revision that has arguably led to an even larger impact (Medical Research Council, 2008). As noted by Peter Craig in the foreword to this book, the second edition arose as a consequence of methodological and theoretical developments in health services research together with a desire to focus on aspects of the topic that had been omitted from the first guidance. This introductory chapter will provide an overview of complex interventions and research methods. It will examine the MRC framework for complex interventions research methods and set the scene for the subsequent sections and chapters, each of which will describe in depth elements of research methods necessary for developing, testing, evaluating and implementing complex interventions in health care and public health.
Learning objectives
• Understand the nature of complexity in health care interventions.
• Consider the need for guidance on complex interventions research methods.
• Be familiar with an overview of the complex interventions research framework.
Given that we as book editors and chapter contributors are focused on ‘complex interventions’, it would be reasonable to define what a complex intervention actually is. It is a relatively simple process to define what we mean by an intervention. Most dictionaries include the idea of an intervention as an action taken for medical purposes. In this book we have extended this definition to mean any action taken by health care workers (including people working in social care and public health situations) with the aim of improving the well-being of people with health and/or social care needs. These actions might also be taken by informal carers, or by people and patients themselves in the form of self-care interventions directed at, for example, better glycaemic self-control by people with diabetes. When we use the term ‘intervention’, therefore, we subsume terms such as ‘activities’ or ‘actions’ often used to describe the work of nurses or other people labouring in health and social care.
Unfortunately, when we turn our attention to our second definitional concept of ‘complex’ the task is not as easy as one might at first assume. What, after all, is a ‘simple’ intervention? It might be assumed that an oral antibiotic agent prescribed by a doctor and taken by a patient in order to reduce an infection is a good example of this simplicity. However, if one takes a moment to consider this proposition, it quickly breaks down.
At the biological level, different people absorb active drug reagents at different rates and amounts. People metabolize the same drug in different ways or even not at all. Gut motility varies. At a psychological level, individual people are motivated differently, have different recall and different views about medication. As a consequence, the drug may be taken exactly as prescribed, sporadically, at an insufficient daily dose and for varying durations, often being terminated before the full course has been taken. Interpersonally, the relationship between the medical practitioner and the patient may influence ‘compliance’ as may the individual’s view of the competency of the doctor. The doctor may have a preference for one drug type over others, and may prescribe according to preference or manufacturer marketing techniques, rather than through evidence. The patient may have an allergy to one type of drug. Even before the medical encounter happens, an individual’s perception of himself or herself as a ‘candidate’ for treatment varies from person to person. This is in itself influenced by both the dominant cultural values of society and the many groups within society to which an individual identifies.
All this, for just a short-term dose of an antibiotic. Pharmacological interventions for mental health conditions, long-term physical conditions and multi-morbidity create additional levels of complexity. On close examination it would seem that there is barely any intervention that we should not consider as ‘complex’. Simple interventions might be merely our desire for simple solutions to the problems of the human condition. Beguiling as it may seem, simplicity is probably a chimera.
Given the above reservations, the current fascination in research circles for the idea of a separate notion of ‘complex interventions’ is slightly puzzling. Indeed, one of the original authors of the MRC framework (Medical Research Council, 2008) has made the suggestion that definitions of simple and complex should not begin with the intervention itself but with the questions being asked in research projects (Petticrew, 2011). He makes the point that if most interventions are inherently complex then it might not be the intervention that determines the most appropriate research strategy, but the questions being posed. ‘Does it (the intervention) work?’ is a very different question to ‘How does it work?’ or ‘What would work in this situation?’ or even ‘How can we optimize it?’ independent of the actual complexity of the intervention itself. Notwithstanding this, registers of randomized controlled trials suggest that almost 50 per cent of entries could refer to trials of interventions regarded by their investigators as complex (http://www.clinicaltrials.gov/ct2/resources/trends; http://www.controlled-trials.com/news/statistics).
Although this sophisticated understanding of interventions and research methods is helpful, it is still necessary to understand what we mean when we talk about the complexity of an intervention. Throughout this book, our contributors return again and again to several important concerns. Of these, perhaps the major one is that of implementation. Whilst we have a full section on implementation, many people believe that it is foolish to develop, test and evaluate an intervention without considering its sustainability and the likelihood it can be routinely adopted by clinical services. The MRC framework describes development, testing, evaluation and implementation as separate, albeit non-linear, steps with important feedback loops to previous and subsequent stages. However, this is really for convenience sake.
As Ingalill Rahm Hallberg notes in Chapter 2 on knowledge generation, although there is a direction of travel through discovery, evaluation and implementation, the route often requires frequent stops, doubling back and retracing of steps. Whilst every journey might start with a single step, most people have an idea where they expect to end up. Complex intervention research methods have been developed to maximize the likelihood that knowledge generated will be ultimately of benefit to humanity. The idea is to be able to develop something useful, demonstrate its effect beyond the vagaries of chance and then embed it in situations where it will bring most benefit. The complex interventions researcher always has an eye on this prize. However, the more complex an intervention, the more difficult it can be to make it a routine part of health care.
Three definitions of complexity are presented in Table 1.1. The MRC definition (Medical Research Council, 2000, 2008) focuses mainly, though not exclusively, on characteristics of the intervention itself and the importance of specifying the individual components, the way in which these components might interact and the amount of flexibility in intervention delivery. It asks researchers to consider the way in which an intervention might be designed to address itself to different groups or organizational targets and to further consider the possible range of different outcomes sought. Latterly, some authors have categorized complexity beyond components of the intervention (Anderson et al., 2013) and have also considered implementation complexity (how an intervention might vary as it is implemented), context (the varied situations in which an intervention is implemented) and participants (the variation in participants receiving the intervention). The final definition cited in Table 1.1 was developed empirically by content analysing authors, descriptions of complex interventions in 207 journal articles (Datta and Petticrew, 2013). This thematic analysis discovered that researchers publishing about complex interventions described them in terms of intervention design, implementation, context, outcomes and evaluation challenges.
TABLE 1.1 Three published examples describing components of intervention complexity
Source
Type of complexity
Sub-themes
Medical Research
Council, 2000, 2008
Behaviours
Number of different behaviours
Parameters of behaviours
Methods of organizing and delivering behaviours
Interactions between behaviours
Difficulty of these behaviours for clinicians and recipients
Outcomes
Number and variability
Delivery
Degree of flexibility and tailoring
Anderson et al., 2013
Intervention
Anticipated effects may be modified by intervention characteristics
Implementation
Anticipated effects may be modified by implementation process
Context
Anticipated effects may be modified by context where interventions are implemented
Participant response
Anticipated effects may be modified by participant characteristics
Datta and Petticrew, 2013
Design
Theoretical understanding
Standardization and treatment fidelity
Implementation
Staffing issues
Patient issues
Context
Outcomes
Multidimensional measures
Assessment methods
Evaluation
Formative and process
It is apparent, therefore, that later definitions have been extended to pay more attention to issues of context and implementation, notwithstanding the fact that the original MRC definition did indeed note their importance. We now think of a complex intervention as much more than the sum of its component parts. Its effects are likely to be modified by both the site and process of implementation. It is likely to have more than one target for change. It is also likely that the more components of complexity present within and between the different elements, the more complex an intervention will be, although one might also argue that some elements (for example the number and variety of intervention components) will have a greater impact on the level of complexity. Crucially, complex interventions present considerable evaluation challenges as they progress along the knowledge development pipeline.
Principles for researching complex interventions
Vast amounts of time and resource are expended in research into human health and well-being, amounting to around US$240 billion annually (Rottingen et al., 2013). From basic scientists aiming to discover underlying disease mechanisms to applied researchers wishing to translate these insights into new therapeutic compounds and regimens, efforts to prolong life and reduce distress preoccupy individuals and societies worldwide. Although tremendous progress has been made, the return on investment is much less than one might expect, referred to by some authors as ‘research waste’ (Chalmers and Glasziou, 2009). This waste arises when the health care research community asks the wrong questions, uses unnecessary or poor- quality research methods, fails to publish research promptly or not at all, and reports research findings in a biased or unusable manner (Chalmers and Glasziou, 2009). In the field of nursing, Rahm Hallberg made a similar observation three years before Chalmers and Glasziou, in that only 15 per cent of papers published in two international nursing science journals in 2005 were addressing ‘research that may carry strong evidence for practice’ (Rahm Hallberg, 2006: 924). Recent reviews have suggested that experimental work comprises no more than 5–10 per cent of research into nursing (Yarcheski et al., 2012; Richards et al., 2014). Given that nursing represents an exemplar of an applied (and complex) science (Richards and Borglin, 2011), these are serious allegations.
Conversely, one of the other reasons behind the efforts to improve research methods, cited in the MRC framework guidance itself (Medical Research Council, 2008), was that promising interventions might be rejected as inefficacious because insufficient effort had been made to develop and pilot test the intervention, or identify and select the right outcome(s) and measures before proceeding to a full clinical trial. Alternatively, many trials fail because of over-optimistic assessments of trial procedures, for example failing to recruit sufficient participants and thereby producing inconclusive results. The most serious problem, however, is in the area of implementation or ‘normalization’ (May and Finch, 2009) of new interventions, a problem that has so bedevilled health sciences that a whole new field of ‘implementation science’ has grown up to address it. Researchers and clinicians can appear to be at loggerheads as the researchers wonder why apparently effective interventions are not widely adopted while clinicians often refer to the unsuitability of carefully controlled, research-based interventions when applied to their own unique clinical context. In some fields many researchers have rejected the idea of experimental trials at all, in favour of observational research, often with a unique qualitative focus. Ironically, therefore, while some health scientists are concerned with preventing badly planned clinical trials of poorly conceptualized interventions from proceeding, others want to see more trials of interventions in areas where traditions have developed that question the validity of clinical trials at all (Richards and Hamers, 2009; Melnyk, 2012).
The MRC complex interventions framework, together with the growing popularity of mixed methods, described by Borglin in Chapter 3 of this book, promised to usher in a new integrative world from that where previous opponents of alternative paradigms would argue vociferously against each other’s positions. The guidance recognized that insights gained from qualitative and descriptive research could provide important contextual information when either developing interventions or understanding how they are received and delivered. The use of alternative evaluative designs was suggested, particularly where randomization might be impossible, difficult or extremely costly. Process evaluations, natural experiments, ‘n of 1’ studies, the importance of feasibility and piloting, and attention to context and implementation issues throughout the knowledge development process were all considered in the guidance. The guidance opened up the world of clinical trials to alternative or additive methods and allowed those suspicious of the usefulness of clinical trials to consider that there might be merit in such endeavours after all.
Central to research methods in complex interventions is that research should be programmatic. The original guidance was also programmatic, but was considered by many to be too linear, apparently based too closely on the process of new drug development. The 2008 guidance retained the idea that interventions can only be taken from ‘bench to bedside’ or ‘campus to clinic’ if a programme of research is sequential and builds upon itself. However, as noted earlier (Anderson et al., 2013) this must not be at the expense of ignoring new, perhaps unexpected, feedback loops from the clinical practice context into the development and testing process itself. McCormack’s Chapter 31 in this book describes one research method that explicitly use...

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