Quality of Life: Assessing the Impact and Benefits of Care to Patients with Fungating Wounds

Disclosure: The study from which this article is drawn, Woundcare Research for Appropriate Products (WRAP), was funded by the Engineering and Physical Sciences Research Council with in-kind contributions from a number of industrial partners. F ungating malignant wounds are caused by tumor infiltration of the skin. Unless amenable to anti-cancer treatments, the infiltration extends, the wounds advance, and the management goals are palliative.¹ The goal of palliative care is to optimize quality of life (QoL) through the control of physical symptoms and attention to individuals’ psychosocial needs.² This suggests that the conceptualization of QoL in the context of palliative care and fungating wounds should focus on dimensions of treatment and care and include psychosocial components, including hope, meaning, and self-esteem.³ Two measurement tools assess and measure the outcomes of fungating wound management together with the impact of the condition on the individual: the Wound and Symptoms Self-Assessment Chart (WoSSAC) and Treatment Evaluation by LE Roux’s method (TELER®).^4,5 Both tools focus on the palliative management of fungating wounds and, although not located in the QoL literature, address QoL issues. The tools differ fundamentally in their approaches to assessment and measurement. WoSSAC is a quantitative self-assessment tool. TELER combines descriptive techniques with a measuring mechanism: assessment and measurement comprise clinical and patient-focused measures, the latter being individually constructed. Both tools raise a number of issues with regard to measurement, specifically where vulnerable patients are involved. The focus of this article is the TELER methodology, including the conceptual framework that underpins the system, which relates to key themes drawn from the health-related QoL literature, such as needs assessment, patient-specific measures, QoL measurement, and quality of care. The Context of the Care of Patients with Fungating Wounds Fungating wounds are caused by tumor infiltration of the skin and its supporting blood and lymph vessels.⁶ This signals the potential impact of fungation on individuals, their families and social networks, clinicians, and health service providers. The skin is not only an important body organ with a myriad of physical functions; it plays a pivotal role in individuals’ socialization, including their personal perceptions and acceptance in the social world. Biological pathways predispose certain tumors to produce a fungating wound, and unless the tumors respond to anti-cancer treatments, the wounds extend with progressive infiltration and damage, in particular, disruption of the blood and lymphatic systems. Without efficient circulation of blood and lymph, skin function is severely impaired with swelling, resulting in congestion and build up of waste materials in the tissues, ultimately causing tissue death. Anaerobic and aerobic bacteria proliferate in these conditions and are sources of malodor and exudate, problems that are commonly associated with these wounds. The location of the primary tumor, together with metastases, may give rise to comorbidities, such as lymphedema or fistula formation, which increase the disease burden.⁷ The full impact on the individuals with fungating disease and their families is encapsulated by Lawton in a study of the dying process.⁸ Using ethnographic methods, Lawton immersed herself in a hospice environment for months to closely observe the experiences of patients with advanced disease. The study analyzed impact of the breakdown of body boundaries and associated odor, loss of control over bodily function, and progressive loss of self. Lawton observed patients and families withdraw from each other, with the patients withdrawing further into a form of social death, before their physical death. However, Lawton also observed that for some individuals palliative care, which comprised the combination of symptom control measures and wound dressings, could restore the body boundaries, and patients could regain a degree of autonomy.⁸ The stated goal of palliative care is to optimize QoL, which is conceptualized in terms of the control of physical symptoms and interventions to support patients’ psychosocial needs.² A number of generic instruments for measuring QoL in palliative care have been developed, one of which is the Palliative Care Quality of Life Instrument (PQLI). This is a 28-item questionnaire comprising 6 multi-item scales in the following 4 domains: physical function, symptoms, choice of treatment, and psychological issues.⁹ Two instruments (WoSSAC and TELER) specifically measure the impact and outcomes of fungating wound care, where the mainstays comprise supportive care, symptom management, disease palliation, and local wound management where wound dressings play a key role. These instruments adopt radically different approaches to measurement, principally the generalization of personal experiences and use of a fixed-item format.^4,5 WoSSAC5 is a 21-item self-administered questionnaire that includes physical problems at the wound site, such as pain, fluid leakage, and bleeding. It also includes psychosocial wound-related items, such as shame, embarrassment, guilt, and impact on relationships with partners. The instrument is intended to measure symptom distress through the severity and interference on daily life of the 21 items. Symptom severity is measured using a visual analogue scale (VAS). The level of interference on daily living is measured using what the authors describe as a 5-point Likert-type scale, ranging from “not at all” at point 1 to “very much” at point 5. This approach to QoL measurement applies the 21 items on the questionnaire to any patient with a fungating wound and raises a key methodological dilemma in terms of the appropriateness of generalizing highly personal attributes in standardized measurement systems. Grocott⁴ illustrated this dilemma in relation to the assessment of odor with a patient with a fungating abdominal wound and fecal exudate. This patient and his wife did not acknowledge odor from uncontrolled fecal discharge, and they conducted a full social life with devoted family members and neighbors.⁴ The self-administered emphasis of WoSSAC invites individual patients to measure their own problems. However, the problems are defined for them in a fixed-item and rating format, including sensitive items, such as shame and guilt, in addition to odor. This approach assumes that all the items are relevant to each individual with a fungating wound, including whether the individuals concerned are able and/or willing to address such issues. Standardization of items in a single instrument is methodologically appealing and facilitates data analysis and generalization. However, it sidesteps the individual nature of the impact, meaning, and experiences of patients who are living with these advanced wounds. The TELER methodology is a generic method of clinical note making that can be applied to any aspect of clinical care.¹⁰ The application by Grocott¹¹ to wound care arose in a study that explored individual experiences of fungating wounds to establish the role and performance of wound dressings in reducing the impact of the wounds on daily life. The study used a multiple-case study design to investigate individual experiences of wound dressing performance in the context of daily living. Forty-five participants were enrolled and followed longitudinally for periods of time ranging from a few days to more than 2 years. TELER was adopted as the tool to record and evaluate outcomes of dressing interventions and other measures of palliative wound care over time. It was selected because it identifies individual needs, defines management goals, and records outcomes at individual and group levels.¹¹ The methodology has been subsequently extended to individual and group-level evaluation of wound care outcomes in the Woundcare Research for Appropriate Products (WRAP) study for patients with exuding wounds of any etiology, including fungating wounds.¹² TELER was not conceived as a QoL measurement tool in relation to fungating wounds. However, the following discussion illustrates how this methodology incorporates a number of the QoL domains that are conceptualized in the literature. In the TELER methodology, these are expressed in quality of care terms. Quality of Life Domains Incorporated in the TELER System The TELER system has 2 main elements: a method of clinical note making and a measuring mechanism. The note-making method records the relationship between care provided and outcomes in terms of clinically significant change. The goals of treatment and care are negotiated with the individual patient. In addition, patients’ experiences of the impact of the wound and wound-related issues, including symptom management, dressing changes, and intrusion on daily living, are articulated in their personal statements, which are incorporated into the measuring mechanism. These statements are generated within the therapeutic relationship between the individual and the clinician. The system thus incorporates a core QoL domain: the focus on the individual.¹³ In addition, the goal setting and outcome measurement mechanisms encompass pivotal aspects of QoL measurement, such as reconciliation of expectations and hopes, mutually defined needs, and continuous QoL assessment.^14–16 Calman¹⁴ maintains that QoL can only be described by the individual and must take into account many aspects of life using an approach that is goal orientated and identifies actions that contribute to individual QoL. Calman’s hypothesis is that QoL measures the difference, or the gap, at a particular period of time between the hopes and expectations of the individual.¹⁴ The structure of the note-making system accommodates these QoL components by defining treatment and care and measuring outcomes. The structure comprises an ordinal scale with 6 reference points, where 5 is the goal, and 0 is the worst case scenario to be avoided or ameliorated. Within the TELER system, goals are negotiated with the individuals concerned. Core clinical knowledge and expertise in relation to symptom management and care of the wound are embedded to provide a focused rationale for interventions that includes a negotiating framework to reconcile differences in perceptions between patients and clinicians. The system includes the physical and psychosocial domains of fungating wound management, symptom control, and local wound measures and takes into account the context of the patient’s daily life. The system thus incorporates the recommendations of Ruta, Garret, and Russell¹⁵ that state goals and expectations should be specified in relation to mutually defined needs: needs that are defined by individuals and healthcare professionals.¹⁵ As it is a clinical note-making tool for in-practice use, the system also enables health-related QoL domains to be routinely addressed.¹⁶ The validity of the measuring mechanism is substantially predicated on the use of sound clinical knowledge, including knowledge of individual patient experiences and concerns, to support the definition of clinically and personally significant change. Change is recorded on the measurement scale, the TELER indicator, and is measured in terms of improvements or deteriorations with the 6 reference points (Figure 1). The reference point definitions (the codes) are framed in plain language that is defined by and, therefore, accessible to patients. The definitions comprise observable, patient-centered treatment and care objectives in the form of outcomes that are clinically significant, because they can be supported by appropriate theory or knowledge. Three types of indicators are included: function, component, and quiz-type indicators. The quiz-type indicator profiles status of the patient on a number of parameters, including satisfaction with care. For fungating wound care, the goal is to trace change in function, physical, and psychosocial deficits linked to outcomes of chronic wound management. The quiz-type indicator is considered superfluous to this focus, and the function and component indicators were utilized. Function and component indicators have been adopted to accommodate the multifaceted nature of fungating wound management and the individual nature of experiences. The function indicators trace a hierarchical change in the patient’s condition. Component indicators are incorporated where the nature of the problem, as experienced by the individual patient, does not follow a hierarchical pattern, rendering function indicators inappropriate. In these circumstances, component indicators are used to identify and measure specific effects of a condition experienced by the individual concerned. Figures 1 and 2 illustrate function indicators, and Figure 3 demonstrates the component indicator. All 3 indicators measure outcomes in relation to exudate leakage, which is a pivotal problem in fungating wound management.¹⁷ Experience to date indicates that patients describe the exudate problem in terms of the core domain, comprising components that include difficulty keeping up with washing soiled clothes, lacking confidence in the dressings, reducing social events, and feeling exhausted by the leakage problem.¹⁷ In addition to the focus on patient perspectives, the method of data collection can be adapted to avoid any potential for negative impact of repeat measures of sensitive issues and intractable problems on respondents. This approach to clinical measurement has been documented in detail elsewhere.¹² For example, with respect to dressings, solving the problem of poor fitting dressings may not be feasible if alternatives are unavailable, and new product design is involved. Data collection at the beginning of an episode of care can be assumed to represent an entire period of care. For example, the individual’s (Figure 4) experience would be coded as “0” on the indicator (Figure 5), because the problem cannot change without a dressing system that can adequately cover the chest wall. Such components would not be revisited unless changes in the dressing system and provision of supplies make predictable and observable changes to the components. The automated system of data analysis can take account of negotiated “missing” data. These facets of the method will be outlined further in relation to the methods of data analysis. Data Analysis Three forms of data are generated from the system: factual information about disease etiology and treatment, written observations by clinicians, and numerical TELER codes. The data analysis has 2 steps. The first comprises a qualitative narrative analysis of the treatment and observational data. The second involves the calculation of 2 indices of the treatment and care given: a Patient Outcome Index and a Quality of Care Outcome Index. The Patient Outcome Index comprises 5 measures of effectiveness, which are calculated from the function indicators. The rationale for separating function and component indicators in the analysis is that function indicators are 2-directional, whereas component indicators are 1-directional. Aspects of recovery, defined in the 2-directional function indicators, can be gained and can be lost. Thus, a code 2, which follows a code 3, shows the loss of 1 of the reference points of recovery that had been gained or a deterioration from a baseline code of 3. The Patient Outcome Index includes the following: • Deficit Index: shows the effect of the problems as they present • Improvement Index: shows the scale of improvement relative to the deficit • Maintenance Index: shows the extent to which the patient’s condition deteriorated since the last assessment • Effectiveness of Care Index: shows the extent to which treatment and care are managed in a therapeutic process • Health Gain Index: standardized index for group-level analysis. The indices are calculated by accounting for clinically significant changes as well as unexplained missing codes, distinct from the aforementioned negotiated “missing” data. Unexplained missing codes are interpreted as care not given that significantly affects the Effectiveness of Care index and account for the fact that continuity of care has been lost (A. A. Le Roux, written communication, December 2004). The Quality of Care Outcome Index provides a quantitative analysis of the individual component indicators. The component indicators are 1-directional in measurement terms for 2 reasons: an experience cannot be eliminated when the cause of the experience is eliminated but can be diminished; and an experience can change when alternative causes arise. For example, when code 3 is recorded, it shows that the patient has experienced 3 components of less than optimal quality of care, and interventions are required to avoid a continuation of this situation. When the interventions resolve the problematic components of care, the patient’s experience jumps from code 3 to code 5 on the indicator. This denotes 1, not 3, clinically significant improvements in the quality of care (A. A. Le Roux, written communication, December 2004). This facet of the analysis acknowledges that patients with conditions, such as fungating wounds, may experience exacerbations in symptoms and problems. Patients will also receive care from different caregivers, which may affect continuity and standards. Both situations need to be effectively managed to avoid the patient re-experiencing unpleasant effects. In the patient example (Figure 4), introduction of a dressing system as illustrated in Figure 6, which covered damaged areas on the chest wall, resolved the components on the indicator (Figure 5). Because this system routinely addresses quality of care dimensions from the individual and professional perspectives, clearly interventions, including dressing products, and related goals have to be continually tailored to needs, which inevitably change in the face of progressive disease, such as fungation.¹⁸ Conclusions The focus of this article has been the TELER methodology applied to the care of patients with fungating wounds. Although not explicitly derived for the purpose of QoL measurement, the conceptual framework that underpins the TELER system relates to key themes drawn from this literature. These themes comprise a focus on the individual, reconciliation of expectations and hopes, mutually defined needs, and continuous QoL assessment. The inappropriateness of generalizing highly personal attributes in standardized measurement systems was illustrated using empirical data. In addition, the sensitive issue of repeat measures for individuals with intractable conditions, such as fungating wounds, and sometimes intractable problems was raised, including the methodological strategy of negotiated missing data that is used to overcome this issue. Acknowledgment More information on the WRAP study can be accessed at https://www.kcl.ac.uk/wrap/. The authors would like to acknowledge the Clinical, Academic, and Industrial Partners of the study. Clinical and Academic Partners: Richardson A (King’s College London); Thomas S (Surgical Materials Testing Laboratory); Cameron J (Oxford Wound Healing Institute); Cameron R (Bradford NHS Teaching Hospitals Trust); Dealey C (University Hospital Birmingham NHS Trust); Gardner W (Bradford NHS Teaching Hospitals Trust); Keogh A (University Hospital Birmingham NHS Trust); Lovatt A (Bradford NHS Teaching Hospitals Trust); Vowden K (Bradford NHS Teaching Hospitals Trust); Vowden P (Bradford NHS Teaching Hospitals Trust). Industrial Partners: Arrowsmith M (3M); Boothman S (Johnson & Johnson Medical); Daun E-K (Mölnlycke Healthcare Limited); Davies A (Vernon Carus); Foster D (Smith & Nephew Ltd.); Fram P (Surgical Materials Testing Laboratory); Gergely AB (Mölnlycke Healthcare Limited); Holmes R (Smith & Nephew Ltd.); Hughes G (Surgical Materials Testing Laboratory); Lane C (3dMD); Lunn K (Medlock Medical); Muldoon J (Activa Healthcare); Robinson T (KCL Medical Limited); Smith R (Focus Product Development); Todd S (UnoMedical); Woods D (Acordis).