DIABETES/METABOLISM RESEARCH AND REVIEWS RESEARCH Diabetes Metab Res Rev 2004; 20(Suppl 1): S13–S18.

Published online in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/dmrr.437

ARTICLE

Psychological aspects of diabetic neuropathic foot complications: an overview

Loretta Vileikyte1 * Richard R. Rubin2 Howard Leventhal3
1 University of Miami, Miami, FL, USA and University of Manchester, Manchester, UK 2 Johns Hopkins University, Baltimore, MD, USA

Abstract
Despite recent advances in understanding and major efforts to control the biomedical risk factors for neuropathic foot complications, the rates of foot ulceration and amputation remain unacceptably high. As the current focus on physical factors alone has not led to a substantial decline in foot complications in persons with diabetes, we propose a more balanced approach with the consideration of potentially important psychological factors. Until recently, psychosocial research in diabetes has almost exclusively focused on self-care behaviours and the burdens associated with the management of glycaemia, almost to the total neglect of the effects of chronic complications including neuropathy. As the burdens associated with the complications of diabetes begin to overshadow those specific to the control of glycaemia, it is important to develop social and psychological concepts and measures that capture how patients perceive and respond to specific threats such as that of neuropathy. There is now some progress in this area as evidenced by emerging patientcentred, theory-based methods to identify psychological factors influencing adherence behaviours, emotional status and quality of life in diabetic patients at high risk of developing foot ulcers. The development of a conceptual model of patient’s common-sense representations or beliefs about foot complications and the type and source of their emotional distress should allow clinicians and behavioural investigators to share ideas for the assessment of patient beliefs and behaviour, and the development of educational methods that should improve clinicians’ ability to empower patients to manage their neuropathy more efficiently. Copyright  2004 John Wiley & Sons, Ltd.
Keywords neuropathic foot complications; adherence; common-sense model (CSM) of behaviour; negative affect; quality of life

Rutgers University, New Brunswick, NJ, USA *Correspondence to: Loretta Vileikyte, Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, P.O. Box 016960 (D-110), Miami, Florida 33101, USA. E-mail: lvileikyte@med.miami.edu

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Background
Peripheral neuropathy is one of the most serious and costly complications affecting individuals with diabetes, as it predisposes them to symptoms such as unremitting pain and unsteadiness, and to incapacitating, end-stage complications of foot ulceration and amputation. Diabetic peripheral neuropathy (DN) is experienced by as many as half of all patients [1], and is associated with substantial health-care costs and socioeconomic consequences, including loss of work time as a result of disability and premature death [2]. It is estimated that 27% of US medical costs attributable to diabetes are due to long-term complications with neuropathy as the second most costly complication [3]. Gordois et al. demonstrated that the health care costs of DN increase substantially when the costs of foot ulcers and amputations are included in the analyses [4]. Most importantly, DN has devastating effects on the individual’s physical and psychosocial functioning and quality of life [5]. This paper is an overview of the key findings from

Received: 4 November 2003 Revised: 2 December 2003 Accepted: 11 December 2003

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recently conducted and ongoing studies on how diabetic individuals adapt to neuropathic foot complications, and focuses on two areas: the impact of neuropathy and its sequelae on the individual’s quality of life (QoL) and emotional state, and the role of psychological factors in guiding adherence to preventive foot care. It elaborates insights into these topics from the framework of the common-sense model of illness behaviour [6], which describes psychological processes from the perspective of the patient.

Diabetic neuropathy and quality of life: the shift from generic to patient-centred, foot problem–focused assessments
Studies of the experiences of DN have shown that symptoms of chronic, unremitting pain, non-healing foot ulcers and amputation are associated with worsened physical and psychosocial functioning [7]. These studies make it clear that DN can be a source of severe symptoms that have a negative impact on the functioning and quality of life, but, because they use generic instruments, they do not describe the specific features of DN, how these features generate dysfunction and how they reduce the quality of life. The findings leave a gap, therefore, between illness as abstractly defined, and the patient’s experience of illness that is essential for framing educational interventions usable in the clinical setting. Moreover, the content of the generic instruments was imposed by the investigators and did not emerge from the patients suffering from DN. It is increasingly recognized that QoL, rather than being a mere rating of health status, is actually a uniquely personal experience, representing the way that individuals perceive and react to their health status [8]. This recognition emphasizes the importance of addressing the patient’s perspective rather than the researcher’s views when measuring QoL. In an attempt to overcome these shortcomings, a foot ulcer–specific quality of life instrument, the diabetic foot ulcer scale (DFS), has been developed to serve as an outcome measure in clinical trials [9]. Unfortunately, the lack of a clear conceptual definition of QoL in this study resulted in the inclusion of several somewhat unrelated scales (e.g. compliance and attitudinal measures), thereby undermining the validity of the DFS (does this instrument measure what it intends to measure?). Finally, it is essential to distinguish between health-related functioning and QoL; whereas general levels of functioning are important, they are not direct appraisals of QoL [10,11]. Individuals can report similar levels of dysfunction and differ in their subjective judgments as to the impact of these dysfunctions on their QoL. Thus, quality of life is what it appears to be, a subjective judgment of quality of one’s life, and not a measure of physical or social functioning or a report of the emotional state [11].
Copyright  2004 John Wiley & Sons, Ltd.

A recent study employed a neuropathy-specific quality of life instrument, the NeuroQoL, to investigate the impact of DN (symptoms and/or foot ulceration) on individuals’ QoL [12]. In this paper, QoL was conceptualized as a product of the individuals’ assessment of their functioning within a variety of life domains affected by DN, which they consider to be important to their QoL, and the integration of these observations into an overall QoL judgment. The results of this study demonstrated that patients experiencing neuropathic symptoms (pain, lost or reduced feeling in the feet and unsteadiness) and/or foot ulcers reported severe restrictions in daily activities (e.g. leisure, paid work and daily tasks), problems with interpersonal relationships and changes in self-perception (e.g. being treated differently from other people). Furthermore, it appears that neuropathic pain and changes in self-perception as a result of foot complications have most devastating effects on individuals’ quality of life. Importantly, the NeuroQoL demonstrated stronger associations than the generic measure, SF-12, with the clinical indicators of neuropathic severity and captured the aspects of neuropathy that influence QoL better. For instance, the mental functioning scale from the SF-12 was neither associated with the markers of DN severity nor explained the relationship between neuropathy and QoL. In contrast, a DN-specific scale of emotional burden from the NeuroQoL was a significant predictor of the effects of DN on QoL. These findings point to the importance of utilizing disease-specific instruments when studying or treating populations that share a common disease state.

Neuropathy and depression: is there a link?
A number of studies examining the association between DN and depressive affect have produced conflicting results, although a recent meta-analysis [13] suggests, overall, that the balance favours a relationship. The large differences in the magnitude of this association across individual studies could be attributed mainly to a lack of agreement in the selection of diagnostic procedures for neuropathy. Moreover, these studies included small samples, assessed painful symptoms only, and neither explored the potential role of other somatic experiences such as unsteadiness or ulcers nor proposed any potential mechanisms by which neuropathy might have resulted in a depressive affect. Several theories have been employed in an attempt to explain how chronic illness generates a depressive mood. While some argue that chronic illness affects depression indirectly, that is, through physical and social dysfunction [14], others suggest that there might be a direct, psychological path [15]. The latter, cognitive theory proposes that the thoughts that define the chronic medical disorder (neuropathy) as a constant, unchangeable part of life, combined with experiences of severe pain or unsteadiness may directly elicit a sense of hopelessness and a depressive affect. The preliminary results of a large
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study of nearly 500 diabetic subjects with DN diagnosed using well-established criteria demonstrated a significant association of DN with depression [16]. Furthermore, the relation between the objective measures of neuropathic severity and depression was mediated (reduced to non-significance) by patients’ subjective experience of neuropathy including pain, lost/reduced feeling and unsteadiness. Somewhat unexpectedly, no significant association between depression and neuropathic foot ulcers was found. Further studies are required to clarify as to why neuropathic symptoms, and not the foot ulcers, produce depressive affect. In addition, the results of this study showed that DN generates a depressive affect via two mechanisms that operate relatively independently from each other: a direct path, by eliciting a set of pessimistic beliefs about foot complications (perceived lack of control over symptoms and their unpredictability, and a sense of self-blame for developing foot problems) and an indirect route, by producing symptoms and related physical and social dysfunction (Figure 1). Furthermore, the effects of symptoms and physical dysfunction on depression were determined by the perceived changes in the self-concept, that is, the self perceived as a family burden. In addition, depression was found to be associated with lower perceived foot care–specific self-efficacy or the patient’s diminished sense of confidence that she/he is capable of carrying out preventive foot care actions. Thus, by undermining one’s sense of competence in one’s ability to engage in effective foot care, depression might lead to foot ulceration through a ‘low self-efficacy-poor adherence-increased foot ulcer rates’ route.

the impact of biomedical risk factors [17], in reality, however, with few exceptions [18,19], ulceration and amputation rates are not decreasing [20,21]. This might suggest that we are missing other important pathogenetic aspects such as psychological and behavioural factors. While it is generally believed that prevention of foot ulcers requires the patient’s active behavioural engagement, very few studies have incorporated behavioural assessment into their designs, and virtually no studies have explored the potential role of psychosocial variables in driving preventive foot care. A recent systematic review of randomized controlled trials (RCTs) evaluated educational programmes for the prevention of ulcers in people with diabetes [22]. The results of these studies, though conflicting, suggest that patient education may have a positive effect on behaviours and may reduce foot ulceration and amputations, especially in high-risk patients. The inconclusive nature of the results may be due to the absence of an assessment of adherence to the intervention or the primary outcome measures (foot ulceration) in half of the studies. Furthermore, all these trials were designed to improve patients’ knowledge about foot-care behaviour and/or enhance their behavioural skills, and none of the studies examined patients’ understanding of DN and its consequences, or their emotional responses to these complications. This could at least partially explain as to why the behavioural change was not achieved in the above studies, as it is increasingly recognized that it is the patients’ commonsense representation or beliefs about their illness that are fundamental in driving their health-care actions [23].

Foot ulceration: the interplay of biomedical and psychological– behavioural factors
Although it is often stated that neuropathic foot ulcers should be avoidable as it should be possible to control

The common-sense model of adaptation to chronic illness
The common-sense model (CSM) of health and illness behaviour provides a structure for exploring how people perceive, give meaning, respond emotionally and make decisions to take specific actions in response to diagnosis and/or signs and functional disability associated with chronic illness [6]. The model has served as a framework for understanding patients’ responses to symptoms and diagnoses and treatment adherence in a wide range of chronic illnesses such as asthma, heart disease, cancer and diabetes [23]. The basic proposition of CSM approach is that patients are active problem solvers, meaning that they interpret their ongoing symptom experiences and information they receive from other patients, family members and health care providers. These interpretations generate common-sense disease models (beliefs), which interact with emotional responses to illness in guiding their health care actions. The main concept of the CSM could be illustrated by a clinical example of a patient with painful neuropathy and no evidence of peripheral vascular disease (Figure 2). His common-sense understanding or ‘folk’ model that the painful sensations in his feet were caused by poor circulation led him to set as a goal, the improvement of the blood supply to his feet. As his
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Objective markers of neuropathy Somatic experiences Pain Loss of feeling Unsteadiness Ulcers

Restrictions in ADL

Neuropathy-induced disruptions in family roles

Depression

Neuropathy-related beliefs
Figure 1. Model of depression in patients at high risk of developing foot ulceration
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Common sense view Goal Vascular model: circulation in feet Action Cut the shoe toebox Result

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Circulation

Pain

Appraisal Pain in toes when wearing shoes Danger !! Allodynia = sense of pain induced by non-noxious stimuli, i.e., pressure from a shoe Bio-medical view Removed non-noxious stimulus Exposed toes to injury

Figure 2. Common-sense, ‘folk’ versus biomedical model of neuropathic pain

actions alleviated pain, thereby confirming his ‘diagnosis’ of poor circulation, this individual continued to engage in potentially damaging behaviours (wear open-end shoes). From the medical perspective, his symptoms could be described as allodynia, which improved when the nonnoxious stimulus, that is, the pressure from the shoes was removed, which then, of course, exposed his toes to potential injury. This clinical case demonstrates that patients respond to foot complications by constructing their own images or models that are inconsistent with the biomedical processes underlying the disease. Unless these misperceptions are ‘uncovered’ and corrected, patients will continue to act upon their inaccurate view of the problem. According to the CSM, patients group their ideas about illness around five characteristic domains: identity, or beliefs about the nature of the disease, what it is (diagnosis) and its symptoms (experience); time-line, the expected duration of the symptoms and condition; consequences, or the perceived and anticipated impact of both symptoms and illness; cause, or the antecedent conditions believed to cause the symptoms and illness; and control, or the perception and expectation that symptoms and illness can be controlled or cured. Each of the five sets of beliefs is represented at both abstract (disease labels, clock and calendar time, abstract notions of outcomes, etc.) and concrete, experiential levels (symptoms, experienced time, imagery of disease and its consequences, etc.). This, at first sight a purely theoretical separation of patient’s cognitive responses to illness into two levels, has important practical implications. It is the concrete experience and disease imagery (development of a foot ulcer or a vivid image of having a limb amputated in response to diagnosis of neuropathy) and not the abstract concepts about illness that arouse emotional responses to threatening outcomes and are powerful guides to preventive actions. Finally, the common-sense problem solving does not occur in a social vacuum; although intrapsychic in nature, illness perceptions are socially generated. Contextual factors such as interactions with health care providers, family perceptions of illness and
Copyright  2004 John Wiley & Sons, Ltd.

support for self-care and medical treatments and cultural and personality factors, play an important role in shaping illness perception at the individual level.

Modelling adherence to foot care: the role of illness cognition, emotion and personality
In a UK/US collaborative venture, Vileikyte and colleagues have used the CSM to develop and validate a method for investigating psychological factors associated with adherence to foot care, the Neuropathy Psychosocial Inventory, NPI [24]. This self-report instrument contains five cognitive subscales measuring patients’ beliefs about foot complications and two subscales measuring emotional responses specific to those beliefs. It has been validated in 494 diabetic patients at high risk of developing foot ulcers, and has been shown to capture reliably patients’ attempts to make sense of the diagnostic label of DN or ‘lost/reduced feeling’ and their concrete, symptom experiences, for example, ‘it is possible to have pain and at the same time a reduced feeling in the feet’. It also assesses patients’ ideas about the nature of foot complications, for example, ‘the development or worsening of ulcers would be accompanied by pain’ or ‘neuropathy means poor circulation’, their causal beliefs or understanding as to how foot complications develop, their sense of control over DN and ulcers and the potential consequences of having neuropathy or a foot ulcer. In addition, the NPI assesses two types of specific emotional responses, fear of foot ulcers/amputation and anger, directed at health care providers as a result of a perceived lack of compassion and lack of clear explanation about foot complications. The initial results of this ongoing study showed that a number of characteristic misperceptions about DN and emotional responses specific to foot complications and their management are important predictors of self-reported foot care behaviour, FCB [25]. Specifically, the presumably accurate perception about
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loss of feeling and a clear vision as to how foot ulcers might develop, that is, how various physical risk factors (dry/hard skin under the feet, changes in foot shape or inappropriate footwear) can cause foot ulcers were significant predictors of FCB. In contrast, a commonsense ‘folk’ model of DN as a circulatory problem was associated with poorer FCB. The list of predictors differed between those with and those without past or present foot ulcers. In those with no ulcer history, a belief that pain is a reliable indicator of developing a foot ulcer was associated with less monitoring such as daily foot checkups. In those with past ulcer history, a set of pessimistic illness beliefs such as perceived lack of control over foot complications and emotions of anger at health care providers and depression were predictive of poorer adherence to foot care. Contrary to the belief commonly held by clinicians that their patients ignore the risks because they use denial as a protective mechanism from being emotionally overwhelmed, the results of the current study did not find evidence for curvilinearity: higher levels of fear of amputation were associated with better FCB. It is important to note that it is not the intensity of fear, but the source of fear or the nature of beliefs underlying emotion that is critical. For example, while fear of complications may lead to medical-care seeking when someone has poorly controlled diabetes on tablets alone, fear may result in avoidance behaviours if it is the potential treatment (e.g. insulin) that is feared. Moreover, while a specific emotion of worry about foot ulcers/amputation appears to motivate preventive actions, generalized (non-specific, not related to illness) anxiety does not seem to affect FCB. These observations are consistent with increasing research evidence that emotional responses that are attached to specific aspects of illness (fear of threatening outcomes such as cancer, AIDS) are important predictors of health-care behaviours in contrast to the weak and inconsistent relationships of illness behaviours with measures of generalized distress [26–28]. Finally, out of the five personality traits (neuroticism, conscientiousness, intellect, extraversion and agreeableness) and personality-like characteristics (hostility), only conscientiousness was associated with better FCB. It appears that conscientiousness affects FCB both directly and indirectly (through patients’ perception of foot complications and through evaluations of practitioners’ expertise). These findings suggest that patients’ perceptions of DN and foot complications are key determinants of FCB. Unlike personality traits, the cognitive and emotional factors assessed by the NPI are expected to be alterable by carefully designed cognitive behavioural interventions to prevent foot ulcers.

common-sense beliefs about DN and its management) is fundamental in driving preventive foot care actions. In addition to its direct effects on behaviour, illness cognition is implicated in eliciting both generalized distress (depression) and specific emotional responses (fear of consequences and anger at clinicians), which in turn either facilitate (fear of amputation) or inhibit (anger and depression) preventive foot care. Understanding how patients elaborate representations of foot complications and assisting them in constructing clearer, more accurate perception of the underlying medical condition is therefore critical for developing effective clinical interventions.

Acknowledgements
We wish to acknowledge grant support from both Diabetes UK and the American Diabetes Association. In addition, for their contribution to some of the work reviewed in this article, we are grateful to A. Garrow, C. Waterman, J. S. Gonzalez, E. C. Bundy, N. Scheffler, M. Becker, J. S. Ulbrecht, P. R. Cavanagh, M. F. Peyrot and A. J. M. Boulton.

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Increasing research evidence suggests that DN may lead to foot ulceration not only via physical pathways but also through an additional, psychological route (nonadherence to foot care). Illness cognition (patient’s
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