Health-Related Quality of Life & Chronic Wounds

  Editor’s Note: Excerpted from Chronic Wound Care: The Essentials and used with permission by the authors. There has been some light editing conducted for space purposes and style.

  There is growing awareness that an individual’s perspective on health and illness represents an important aspect of his/her healthcare. Clinicians can adapt treatment plans to individual needs if they understand the patient’s perspective. Much of the current healthcare reform initiative is focused on a “patient centered” approach to care, which necessitates a better understanding of the patient’s priorities. Furthermore, patient-reported outcomes represent a valid way to measure the effectiveness of care.   The way this information is reported is formalized using patient-reported outcome measures (PROMs). The Centers for Medicare & Medicaid Services (CMS) now requires residents in long-term care facilities to be interviewed about their quality of life as part of the Minimum Data Set (MDS) 3.0 regulatory process. CMS is also requiring more patient reported outcomes in wound care clinical trials as well as in quality initiatives such as the Physician Quality Reporting System (PQRS). While not mandatory in the outpatient wound clinic, the use of PROMs can nonetheless be valuable.

What is Quality of Life?

  The term “quality of life” first appeared in the US in the 1950s as a slogan to represent “the good life.” More recently, it has become part of a holistic view of the individual within the healthcare system. Quality of life is a broad concept that reflects an individual’s level of satisfaction in a variety of situations, including housing, recreation, and environmental conditions. Since this can be affected by factors well beyond health status, it was necessary to develop ways to specifically assess health-related quality of life (HRQOL), which refers to the impact of health and illness on objective and subjective functioning and well-being. HRQOL is a complex multidimensional concept that reflects the total impact of health and illness on the individual. However, many studies infer improvements in HRQOL from change in a single clinical parameter, usually pain. While all those involved in wound care acknowledge the profound impact pain can have on an individual, it is important to note that pain and HRQOL are not equivalent concepts. PROMs include a range of validated tools that are designed to measure either a person’s perception of his or her general health, or a specific condition such as the effect of a wound (or even a particular type of wound) on their quality of life.

Why Measure HRQOL?

  Improving HRQOL is now being recognized as an important outcome measure for a range of interventions. They are particularly important for people living with chronic conditions or those receiving palliative care, and can be grouped under three headings: clinical practice, research, and quality improvement/quality assurance.

  Clinical practice: During routine clinical practice, healthcare professionals intuitively take into account life-quality issues when making clinical decisions. HRQOL data may be particularly relevant when expensive or hazardous options need to be considered for those patients not healing with the use of conventional treatment. With the increasing costs associated with patient care, HRQOL may be a useful measure for allocating finances to patient care. There is, as yet, no “gold standard” to measure cost effectiveness or to analyze costs. Nevertheless, at some point in the development of appropriate formulae, the “human” cost needs to be considered. On the individual level, considerations about treatment options may be influenced by the aspects of living with a wound that have the greatest impact on the person. At the population level, HRQOL data are generally considered valid indicators of service needs and intervention outcomes.

  Research: HRQOL data may prove to be useful as an additional outcome measure for research in wound care, as an alternative to “days to healing” (particularly for those patients for which healing is not a realistic option), or as an additional measure of effectiveness of the clinical treatment plan. In some areas, HRQOL has become an accepted endpoint in clinical trials, particularly when comparing treatments with similar or no impact on disease progression or survival. The development of new therapies, particularly those using new technologies, should include HRQOL data since resources may be devoted to the development of a new technique or treatment only to find that it is not acceptable to patients. CMS is now regularly requiring that patient-reported quality of life data be collected during clinical trials.

  Quality improvement/Quality assurance: HRQOL data may be extremely useful within quality improvement or quality assurance programs as a means of measuring change. Measuring HRQOL can help identify the burden of disease and disability, and help countries monitor health objectives.

QOL & Chronic Leg Ulceration

  There are probably more data on quality-of life issues and patients with leg ulceration than any other wound type due to the qualitative and quantitative work undertaken in the early 1990s. A synthesis analysis in 2007 included 12 qualitative studies from the US, Australia, Sweden, and the UK that identified five common themes: physical effects of leg ulceration, describing the leg ulcer journey, patient-professional relationships, cost of a leg ulcer, and psychological impact. Living with the physical symptoms associated with an open, chronic wound dominated the data from all 12 studies. These physical symptoms included pain, odor, itch, leakage, and infection. The synthesis also demonstrated how many patients had initially been guided by their own health beliefs and aided by family members before accepting that the wound was not a “simple scratch” and that professional help was needed. The relationship with the professional was described in both positive and negative ways. Positive themes focused on therapeutic value, strategies to cope with a chronic condition, and aiding patients in regaining control of their lives. The negative comments included disputes between patients and health professionals and being given conflicting advice. Across a number of studies, patients perceived a lack of time, trust, empathy, and understanding by healthcare professionals.

  Patients often felt they were not listened to. Many patients reported feelings of embarrassment associated with the leg ulcer, the negative impact on body image, fear of amputation, depression (in some cases linked to suicidal thoughts), and a general sense of identity loss as the wound dominated their lives. The authors concluded that many professionals work to a code of practice whereby the emphasis is on the route to healing, with the assumption that a healed wound will improve quality of life. However, from the patient’s perspective, healing may not be the most appropriate route for those living with large, hard-to-heal wounds as this may “initiate a spiral of hopelessness.” A more recent review confirmed that physical symptoms, especially pain, dominate everyday living with mobility, sleep disruption, exudate, and odor — all causing significant problems. Extensive data suggest that health professionals need to find better ways to address these patient concerns.

  Recent studies also suggest the results of generic HRQOL are difficult to relate directly to the effect of the leg ulcer separate from the patient’s other comorbidities. A growing number of condition-specific tools have been developed.

  The Cardiff Wound Impact Schedule has been shown to be a valid and reliable condition-specific tool for chronic wounds of the lower limb. This tool has been recommended as a research outcome measure when evaluated for use in people living with diabetic foot ulcers (DFUs). Additionally, the Institute for Health Services Research in Dermatology and Nursing in Hamburg, Germany, has developed the Wound Quality of Life Index (W-QOL), which has been translated into English and validated. A simple, 17-question tool specific to the effect of a wound on quality of life, the W-QOL has been accepted by CMS as a quality measure for the PQRS through the US Wound Registry’s Qualified Clinical Data Registry. (For more information on the W-QOL, see page 14 of this issue of TWC.)

Quality of Life & Pressure Ulcers

  A systematic review in 2009 included 31 studies with 2,463 patients, including the frail, elderly, and those living with spinal cord injury (SCI). Collectively, these studies covered key themes from physical restrictions, social isolation, impact of wound symptoms, body image, and self-concept, as well as the importance of the relationship between the patient and the healthcare provider. The major issues raised were related to severe wound pain and the concern that healthcare providers did not listen to patient concerns, particularly in relation to responding to early warning symptoms of deterioration. Many of those who develop pressure ulcers are elderly and frail with profound mobility problems and a range of additional concomitant disorders. High-quality, large-scale studies using validated tools are still urgently needed. The age range of patients included in this review and the range of conditions included make it difficult to assess whether the issues raised by those living with SCI are the same as those who are elderly.

QOL & DFUs

  Recent studies have shown that the emotional status of the person at the time when the first diabetic ulcer appears can have long-term consequences for the individual. A five-year follow-up study has shown a two-fold increase in mortality for those with depressive symptoms at initial presentation. Research work using generic questionnaires to measure HRQOL have indicated that people living with DFUs have a significantly poorer quality of life than those living with diabetes but no DFUs. Studies on the life quality of people living with DFUs have emphasized that this is a life of fear, mainly of amputation but also infection, with wound pain being an underestimated problem in this group. For people living with diabetes, ongoing experiences of pain affected the ability to sleep and impacted mobility and social life. These people also described feelings of depression, isolation, and loss of independence. Patients with unhealed ulcers were frustrated with healing and had anxiety about the wound, reported problems with a range of activities of daily living, had problems with footwear, and complained of a limited social life. A greater understanding of these issues should help tailor clinical practice to assist patients while they live with ulceration and work to adopt positive self-care as a preventive measure against further deterioration.

Need for More Awareness

  Compared to trials in other patient populations (eg, cancers, AIDS, asthma), relatively few randomized, controlled, chronic wound trials have included HRQOL data, although some studies are now including such measures as secondary outcomes. Yet, anyone who spends even a short amount of time with a frail, elderly patient who is house-bound with large wounds on both legs cannot help but be moved to appreciate the impact of living with that condition on everyday life. The data are now consistently proving that the quality of life of patients who are living with chronic wounds is very poor. The challenge for the future is to ensure that we pay as much attention to HRQOL and life quality as we do to other important clinical parameters and start to build new ways of delivering care that ensure patients’ well-being is the central focus. We will have to begin with learning to measure quality of life at it relates to wound care.