Understanding Patients’ Experiences of Treatment Burden in Chronic Heart Failure Using Normalization Process Theory

Dear editor,

In their recent article, Gallacher and colleagues [1] draw our attention to the important issue of treatment burden. They set out to assess the burden associated with treatment among people living with chronic heart failure and to determine whether Normalisation Process Theory (NPT) is a useful conceptual framework for that analysis.

Their rigorous, secondary qualitative analysis of interview data delivers on both counts. The data elucidates clearly the extensive work undertaken by patients to manage and integrate treatment routines into their daily lives. The breadth and depth of their qualitative analysis is a function of their use of NPT as a heuristic device to sensitise thinking about the work involved in implementation processes. Specifically, the analysis provides knowledge about both individual and collective action by patients, their families and healthcare professionals and, importantly, the various interactions that take place between these actors in a variety of settings.

It is important to highlight two key features of this research. First, the analysis of patients and their healthcare work is taken as a starting point and, second, there is attention to implementation work undertaken in healthcare and home/community settings. Taken together, this represents an important departure for NPT analyses which, more usually, start with focus on healthcare work by professionals in formal healthcare organisations [e.g. 2-3]. Therefore, this analysis reveals considerable scope for new uses of NPT in future primary care research.

Related to this, the authors conclude that this analysis requires patient endorsement of their findings. Given long standing policy imperatives to involve service users in primary care research and development projects [4], it would be valuable to consider the ways in which patients with chronic conditions could be involved in the research, particularly, the analysis phase. This would be an interesting way to explore the perspective offered by NPT as a conceptual framework for analysis along with patients’ emic [insider] perspectives of their own healthcare work. This would bring a valuable patient-centered approach to a research process that aims to develop new targets for treatment and quality improvement efforts toward patient-centered care.

1. Gallacher, K., May,C.R., Montori, V.M. and Mair, F.S. Understanding Patients’ Experiences of Treatment Burden in Chronic Heart Failure Using Normalization Process Theory Annals of Family Medicine 2011; 9: 235-243

2. Gask, L., Rogers, A., Campbell, S. and Sheaff, R. 'Beyond the limits of clinical governance: the case of mental health in primary care' BMC Health Services Research 2008, 8: 63.

3. Elwyn, G., Legare, F., Edwards, A., van der Weijden, T. and May, C. 'Arduous implementation: does the normalisation process model explain why it is so difficult to embed decision support technologies in routine clinical practice', BMC Implementation Science 2008, 3: 57.

4. World Health Organisation, Alma Ata Declaration. WHO, 1978, Geneva.

Competing interests:   Anne MacFarlane is an international participant at the Normalisation Process Theory UK National Institute of Health Research, School of Primary Care Research, Peer Learning Group Meetings

We wish to thank Dr Summers for her helpful comments. We think she has identified a key issue, namely, that NPT might prove useful to identify areas of difficulty for patients when managing their chronic condition. We believe this to be the case and expect that increased understanding of the phenomenon of treatment burden will help inform the development of appropriate interventions.

It is worth pointing out that Dr Gallacher's PhD is aimed at increasing understanding of treatment burden in stroke patients and that members of our International Group for the Study of Treatment Burden are also examining this issue in diabetes.

Competing interests:   None declared

Gallacher, et al.’s use of Normalization Process Theory (NPT) for examination of patient’s experiences of treatment burden with heart failure is novel. NPT has typically been applied to the understanding of the implementation and normalization of complex interventions in organizational settings. To use this theory as a lens in which to better understand how completing the tasks of chronic illness care from the patient perspective is of interest. Breaking the treatment burden issue into the coding frame of the NPT regarding the various areas of work for the patient (sense-making, relationship, enacting and appraisal) sheds light regarding where patients may have difficulty in caring for their chronic condition. This may be useful for providers such as physicians and care managers in assessing where help is needed. I would be interested to see NPT applied to other chronic conditions.

Competing interests:   None declared

We wish to thank Dr Blakeman for his thoughtful and very insightful comments regarding our paper and how our work resonates with the literature relating to the management of long term conditions. We similarly believe that NPT provides a useful framework for conceptualising some of the existing evidence in this sphere.

We believe he is correct in suggesting that determining exactly how best to lessen treatment burden is likely to be a complex issue. We would draw his attention to the earlier comments by Dr Eton about the need to develop a measure of treatment burden in order to be able the assess the effectiveness of interventions to lessen treatment burden and believe that this will be an important area of investigation.

Competing interests:   None declared

We appreciate Prof Schocken’s comments and thank him for taking the time to contribute to the discussions about our paper. Our responses to the issues he has raised are as follows. First, with regards to our sample, Prof Schocken is concerned that it may not be “representative of chronic heart failure patients who are most likely to face the heaviest treatment burden,” whom he suggests are often passed onto cardiologists or even heart failure specialists. We can allay his concerns, as in the UK, while patients with severe heart failure may indeed be referred to cardiologists or even heart failure specialists; the primary care provider maintains responsibility for the patients. Such patients remain registered with family practitioners and thus, participants in our study included those who had been referred for specialist care and thus could be expected to include the “more heavily burdened” patients.

Second, he raises concerns about how we have defined heart failure, suggesting that including only those with “low left ventricular ejection fraction is too simplistic”. We would agree that many heart failure patients have preserved systolic function, and thus our inclusion criteria could be viewed as another potential study limitation. However, we would argue that there is no particular reason to expect that the experiences, in relation to treatment burden, of heart failure patients with preserved systolic function should be vastly different. It is of course up to the reader to assess the potential generalisability of our findings beyond the patient population described. The inclusion criteria selected were chosen merely to ensure we had a fairly tightly defined population. With regards to these first two points, it may also be of interest to know that the authors are in the process of carrying out a second study aimed at further exploring treatment burden in chronic heart failure patients, for which we are purposively recruiting patients with varying degrees of illness severity.

Thirdly, and most importantly, it has been suggested that our results are less useful because they are “presented as anecdotes rather than as the results of analyses of their interviews using the NPT construct” and that the listing of frequency distributions of the challenges faced by patients would have been helpful. It is important to clarify that we did indeed analyze all the data using the NPT constructs and Table 2 in the paper, titled, “Normalization Process Theory Coding Frame for the Treatment Burden of Chronic Heart Failure” was intended to show the coding framework used while our taxonomy of treatment burden is included in the paper, see Supplemental Table 1 (available at http://www.annfammed.org/cgi/content/full/9/3/235/DC1). This taxonomy categorises the data into four separate sections that represent each of the four NPT constructs, namely coherence (“Learning about treatments and their consequences”); cognitive participation (Engaging with others); collective action (Adhering to treatments and lifestyle changes) and reflexive monitoring (Monitoring the treatments). Quotations are provided within the text to highlight the issues raised as is standard practice in papers presenting qualitative data.(1,2,3,4) The use of quotations and the data within our supplemental table allows the reader to form a judgement about the validity of our interpretation of the data and is not meant to serve as anecdotal evidence.(1,2,3,4) It has been suggested that good qualitative analysis is able to document its claim to reflect some of the truth of a phenomenon by reference to systematically gathered data, focused on a coherent line of inquiry (3,5) and we would suggest that our paper fulfills these criteria. We contend that frequency distributions or counting exercises of qualitative data from a purposive sample of just 47 people are unlikely to be informative.

Interestingly, Prof Schocken suggests that disease prevention is the greater challenge and wonders whether NPT might bring useful insights to that problem. We would strongly agree with these sentiments and have plans to investigate just that issue in the future, as we believe NPT could provide a very useful conceptual framework for considering that problem.

Finally, a minor point of clarification, the patient interviews in this study were undertaken in the United Kingdom, but in England rather than Scotland.

References

1. Murphy E, Dingwall R, Greatbatch D, Parker S, Watson P. Qualitative research methods in health technology assessment: a review of the literature. Health Technology Assessment 1998;2.

2. Dingwall R, Murphy E,Watson P,Greatbatch D,Parker S. Catching goldfish: quality in qualitative research. J Health Serv Res Policy 1998; 3: 167–172.

3. Pope C, Ziebland S, Mays N. Qualitative research in health care. Analysing qualitative data. BMJ2000;320:114-6.

4. Mays N, Pope C. Qualitative research in health care. Assessing quality in qualitative research. Br Med J 2000;320:50-2.

5. Fielding N, Fielding N. Ethnography. In: Fielding N ed. Researching social life. London: Sage, 1993: 155–171

Competing interests:   None declared

Using Normalization Process Theory (NPT) as a framework for secondary analysis of qualitative data, the authors have sought to identify and understand health care work that patients undertake when living with chronic heart failure. In accordance with the underlying theory, the paper highlights a set of practices to be considered when developing complex interventions to improve the quality of care for people with long-term conditions.

The key components (themes) presented resonate with existing literature and policy surrounding long-term condition management.(1,2) Within the context of disease management, supporting self-management is considered to entail helping patients to a) understand their condition(s), b) deal with medicines, c) improve lifestyle behaviours, d) monitor the condition and deal with flare ups, and e) access peer networks and community services.(1,2) As such, through NPT, the article provides a structure (see Figure1) to an existing evidence base and suggests that key areas of health care work have been identified. However, in mapping closely onto known self-management practices, it also raises the question of how the concept of ‘treatment burden’ is distinct from the phenomenon of ‘self-management’?

The paper outlines types of health care work embedded in peoples’ lives, with effort required to make sense of and live with chronic heart failure. A next step is to ensure that this ‘patient work’ is less burdensome and more meaningful, with a need to guarantee that process and health outcomes are considered and measured in the broadest sense. Historically, self-management practices (‘patient work’) have not consistently been measured during the evaluation of complex interventions in health failure.(2) In addition, the effect of existing self-management interventions on the quality of life for people with heart failure remains equivocal.(2)

The authors acknowledge that the study lists a range of activities undertaken by patients around chronic heart failure but does not provide information about the relative importance of components of this burden. A further issue to consider is how these different activities relate to one another in practice. Hypothetically, attempts to reduce the disruption experienced by reducing the number of self-management topics covered in a particular consultation, may be offset by exacerbating the burden through increased health service visits. Pre-consultation templates, which are known to change clinical dialogue,(3) are a potential mechanism to help prioritize patient needs and preferences, and in doing so ensure global quality of life issues frame health encounters.(4)

Finally, studies that entail comparative analysis of both interview accounts and observational data may help to understand the relevance of organizational structures, such as clinical information systems, and how they may support or disrupt dialogue around ‘patient work’ in healthcare settings.(5)

References

1) Department of Health. Supporting people with long term conditions: An NHS and Social Care Model to support local innovation and integration. 2005. London, Department of Health.

2) Riegel B, Moser DK, Anker SD, Appel LJ, Dunbar SB, Grady KL et al. State of the Science: Promoting Self-Care in Persons with Heart Failure: A Scientific Statement from the American Heart Association. Circulation 2009; 120(12):1141-1163.

3) Kinnersley P, Edwards A, Hood K, et al. Interventions before consultations to help patients address their information needs by encouraging question asking: Systematic review. BMJ 2008; 337: 485.

4) Kennedy A, Chew-Graham C, Blakeman T, Bowen A, Gardner C, Protheroe J, Rogers A, Gask, L. Delivering the WISE (Whole Systems Informing Self-Management Engagement) training package in primary care: learning from formative evaluation. Implementation Science 2010; 5:7.

5) Blakeman T, Chew-Graham C, Reeves D, Rogers A, Bower P. The Quality and Outcomes Framework and self-management dialogue in primary care consultations: a qualitative study. Br J Gen Pract 2011 (in press).

Competing interests:   None declared

Schocken DD. Comment on Gallacher et al. Ann Fam Med 2011;9:235- 243.

Chronic heart failure continues to pose an enormous challenge to patients and care-givers. Gallacher and colleagues (1) present a view of this challenge from a new and refreshing perspective. Their application of Normalization Process Theory (NPT) to examining treatment burden is an approach where interviews with patients have been analyzed with the intent to categorize the treatment process from the viewpoint of challenges to the patient posed by each level of care from personal self-care to broader population systems of care, in this case those of Scotland.

The primary strength of the paper is its novelty as a systems approach to a very human challenge, care of a severe chronic illness. Chronic heart failure requires frequent practitioner interactions, visits to the hospital or clinic for monitoring of various clinical parameters, multiple pharmacy visits for adjustments to many medications, and required interactions with social services or financial support organizations.

On the other hand, there are three major limitations to the study that are not emphasized enough by the authors. First, the population sample is both loosely characterized and possibly not representative of chronic heart failure patients who are most likely to face the heaviest treatment burden. Those most severely affected patients are already passed on to specialist cardiologists or even more subspecialized heart failure physicians. These referrals occur because the burden placed on the primary care providers over-taxes the already time-pressured and resource-strapped workday of the family practitioner. Second, the definition of heart failure is not well-characterized. Confirmation of heart failure by demonstrating low left ventricular ejection fraction is too simplistic, especially when nearly half of all chronic heart failure cases in the population have preserved left ventricular systolic function. Lastly, and most importantly, although the authors acknowledge that their study is qualitative and needs further prospective investigation, their results are presented as anecdotes rather than as the results of analyses of their interviews using the NPT construct. The listing of frequency distribution of the many challenges faced by patients in the management of their chronic heart failure would have shed light on possible targets for changing management approaches.

Enhanced tools for self-care and development of patient-centered disease management programs utilizing case managers to orchestrate care and navigate the complexity of managing complicated chronic disease are but two potential ways of increasing attention on treatment rather than on illness. Disease prevention remains the larger and more elusive problem. We all wonder what the NPT approach will bring to that riddle.

Reference: 1. Gallacher K, May CR, Montori VM, and Mair FS. Understanding Patients’ Experiences of Treatment Burden in Chronic Heart Failure Using Normalization Process Theory. Ann Fam Med 2011;9:235-243.

Competing interests:   None declared

I wish to thank Dr Eton for his very helpful comments. Our research group agree wholeheartedly with his comments and concur that development of a generic measure of treatment burden will be an important step. In order to develop such a measure it will be essential to develop a clear conceptual framework of the key aspects of treatment burden that cut across health care conditions. Our group is currently examining the issue of treatment burden in individuals with stroke and diabetes, using a range of methods, to help contribute to the development of such a framework. While it is crucial to be able to define the phenomenon accurately it is also important to highlight that the aim of all this effort is to ensure that we can develop methods of care delivery that are "just right" (http://minimallydisruptivemedicine.org/)for those suffering from a range of health care conditions.

Competing interests:   None declared