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Outcome and quality of life in medicine: A conceptual framework to put quality of life research into practice
Urologic Oncology: Seminars and Original Investigations 23 (2005) 186 –192
Seminar article
Outcome and quality of life in medicine: A conceptual framework to put quality of life research into practice Michael Koller, Ph.D.a,*, Monika Klinkhammer-Schalke, M.D.b, Wilfried Lorenz, M.D.b a b
Institute of Theoretical, Philipps-University, Marburg, Germany Tumor Centre, University of Regensburg, Regensburg, Germany
Abstract It is rather counterproductive to get caught up in never ending discussions on what quality of life (QOL) is and whether it can be assessed. This article is based on the idea that it is much more important to improve the conceptual frameworks that allow the use of the QOL concept in clinical practice. Survival of the QOL concept within the medical community will depend on its contributions to a better understanding of patients and to improving patient care. It is important to accept that QOL should not be viewed in isolation but in synopsis, with other psychologic concepts and clinical data. We propose a profile format that presents QOL data in a way that is easily accessible for clinicians, allowing action to be taken immediately. QOL profiles are never a substitute but a starting point for a patient-doctor interaction. A profile driven interaction has the potential to be structured, efficient, and leading to action. © 2005 Elsevier Inc. All rights reserved. Keywords: Quality of life; Clinical practice; Integrated outcome model
Introduction Problems with traditional concepts of health and quality of life A major issue of debate in quality of life (QOL) research today is the clinical relevance of QOL information. What does QOL mean in a clinical setting, and what are clinically meaningful QOL differences/changes? Is a value of 48 (on a scale of 0⫺100) good or bad QOL? Is a change from 48 to 61 an important improvement in a patient’s condition? Various efforts were made to settle these and related issues: computerized QOL assessment with subsequent information of doctors [1]; identification of score changes that patients perceive as minimally important [2]; identification of clinically relevant effect sizes by using statistical procedures [3,4]; and comparison of an individual’s QOL score with normal reference scores [5,6]. Our concern is that these suggestions are either too technical or too statistical and fail to consider that the kernel M.K. was supported by a BMBF-grant 01GT0303 (Pflegeforschungsverbund Mitte-Süd). The work described in this article was funded in part by a grant from the Bavarian Ministry of Health (“Bayern aktiv”). * Corresponding author. Tel.: ⫹49-6421-2862250; fax: ⫹49-64212868926. E-mail address: [email protected] (M. Koller). 1078-1439/05/$ – see front matter © 2005 Elsevier Inc. All rights reserved. doi:10.1016/j.urolonc.2005.03.002
of many problems lies in the conception of QOL as such. This can easily be illustrated with 2 World Health Organization (WHO) definitions, which have served as the starting point of most subsequent QOL definitions in medicine [7]. WHO definition of health Its definition is: “A state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.” WHO definition of QOL The definition is: “Quality of life is defined as an individual’s perception of their position in life in the context of the culture and value system in which they live and in relation to their goals, expectations and standards and concerns. It is a broad ranging concept affected in a complex way by the person’s physical health, psychological state, level of independence, social relationships, and their relationship to salient features of their environment.” These definitions are encompassing and idealizing and, consequently, are totally impractical from a clinical point of view. Which doctor would be able to “treat” the cultural context of his/her patients? Can the complete absence of disease really be an achievable treatment goal in a clinical
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setting? It is obvious that merely technical or statistical improvements, such as computer-aided diagnosis or the specification of effect sizes, are hardly helpful to answer such questions. Very clearly, numerous conceptual steps are necessary to make the QOL concept suitable for the clinical arena. Our approach is based on the following 4 premises: (1) a concept of disease related QOL; (2) the definition of thresholds, allowing to distinguish between acceptable QOL and unacceptable symptom burden requiring action; (3) the availability of comprehensible and action-oriented QOL diagnostics; and (4) implementation of the QOL concept/diagnostics into routine patient care and the availability of effective therapeutic options. Fig. 1. Three-component outcome model.
Integrating the medical paradigm and disease-related QOL: A 3-component outcome model As a first step, the role of QOL in the context of more accessible classical endpoints has to be clarified. QOL is not a surrogate or a competitor with traditional endpoints, such as survival, complication rates, or length of hospital stay. Moreover, when assessed in patients, QOL is not related to health (as is suggested by the term “health-related” QOL) but is rather related to a particular disease. The psychologic situation and, consequently, the concept of QOL of ill people are different from “healthy” or “normal” people. Differences exist in a number of aspects: ● Patients possess an attribute that is socially and personally undesirable, namely an illness. ● They want to get rid of this condition, resulting in an avoidance orientation to get from one state to another. ● Patients have to enter (or are forced into) a particular social interaction with individuals that rank very high in the social hierarchy; patient’s emotional reactions to these individuals will be particularly high, and may range from helplessness to trust and hope. ● A patient’s physiologic/biologic state is different, alleviated levels of cytokines or killer cell activity may affect psychologic states and, as a consequence, questionnaire responses. ● Specific conditions (e.g., palliation) are outside the realm of “normal” everyday human experience, therefore, specific assessment instruments are necessary [8,9]. This viewpoint is very different from a “having fun” stereotype of a good QOL. The implication is that a patient’s QOL can only be understood in the context with his/her medical condition record. To be more specific, a patient is best described in terms of 3 components [10,11]: classical, mechanistic endpoints (survival, complication rates, laboratory parameters, imaging); patient-based or hermeneutic endpoints (QOL, expectations, stigma); and a value judgment in a functioning patient-physician relation-
ship to decide which of these possible measures is the most relevant one for a patient in a given clinical situation. The 3-component outcome analysis is necessary for recognizing the relations among the various endpoints and for defining an empirically derived hierarchy (ranking). The major distinction between the 2 halves of the faces in Fig. 1 is that the left half is physician-assessed, whereas the right half is reported by the patient himself/herself, based on personal perceptions, impression, feelings, and reactions. Furthermore, the 2 halves of the face reflect the fact that patient’s responses are not 1:1 related to objective health parameters. Numerous psychosocial variables play a role as investigated in various studies. Overall, somatic symptom distress was highly correlated with the psychologic variables “negative affect” (r ⫽ 0.70⫺0.75), “experienced social stigma” (r ⫽ 0.51), “social desirability” (r ⫽ ⫺0.50), and “positive thinking” (r ⫽ 0.40 or ⫺0.40, depending on whether positive affect or compensatory selfrelated positive thinking was dominant) [12–14]. A comparable pattern of results was observed when these variables were correlated with global QOL as the quasi-dependent variable. However, both somatic symptoms and global QOL were practically unrelated to objective clinical criteria (tumor growth, findings of imaging techniques, carcinoembryonic antigen level, and external physician’s overall judgments) [12–14]. In summary, it becomes clear that QOL is a domain outside the mechanistic viewpoint of the biochemical/molecular biologic paradigm. Therapy related expectations were investigated in a study of patients with cancer undergoing radiotherapy [15]. Although most patients had advanced forms of cancer and they were treated according to a palliative therapeutic regimen, almost 2 of 3 expected a cure from therapy. Although all patients had been fully informed, many of them would not give up healing expectations. Psychologic processes like these are discussed in the literature under the labels “positive illusions” [16] and denial [17]. The corollaries of therapy related expectations were remarkable: patients who
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expected a cure had a significantly better QOL before therapy, but those who expected pain relief had a significantly worse QOL. However, when patients realized that their expectations were not fulfilled, they had particularly low levels of QOL after therapy [15]. Thus, expectations apparently go into 2 fundamentally different directions, good or bad QOL. For clinical purposes, we have to know for individual patients what their expectations are like. When asked which outcome was most important to them, patients who were about to undergo cholecystectomy [18] had a strong preference for items such as “to regain physical fitness as quickly as possible” or “to become the same as before the disease.” This result was extremely surprising, as in none of the more than 60 studies comparing laparoscopic and open cholecystectomy, the return-to-physical-fitness variable has been the primary endpoint: cosmetics and low levels of pain were considered to be most important. Because many of these trials had high methodological standards (prospective, randomized) and used reliable and valid outcome measures, their findings are considered to be formally correct. However, it is likely that these studies have assessed correctly the wrong issue, namely, outcomes that were more important to doctors than to the affected patients. Several questionnaires (European Organization for the Research and Treatment of Cancer [EORTC], RAND 36Item Health Survey) allow for a person’s overall judgment of QOL [19,20]. This overall judgment must not be confused with the aggregation of a summary score across different QOL components, as preferred by other questionnaire approaches [21,22]. On the level of individual patients, clinical experience teaches that some patients who have considerable health problems, which they also openly admit, still rate their “overall” QOL as relatively good. On the level of larger scale patient samples, regression analyses show that objective health parameters and self-reported health variables do not fully explain the variance of global QOL [12,13]. Furthermore, it has been shown repeatedly that individuals often report relatively high levels of QOL, despite the fact that their health is severely impaired. A particularly well-known and dramatic example was described by Brickman et al. [23], who found that after a certain adaptation period, paraplegic accident victims and lottery winners reported practically the same average level of overall well-being. In the literature, this phenomenon is called “well-being paradox” [24]. It appears plausible that an overall judgment of QOL includes a component of coping, reflecting how well the patient can handle his/her life situation when facing a health problem [25]. In summary, these findings clearly show that QOL, as currently assessed in standardized questionnaires, is not an isolated concept but has to be regarded as one facet in a whole spectrum of variables. This notion is particularly important when it comes to diagnosing patients (see “QOL assessment: Integrative, clinically meaningful, and action oriented” section).
Thresholds: Distinguishing between acceptable QOL and unacceptable symptom burden A typical remark often expressed by QOL skeptics is: “We are aware of these questionnaires, but they did not change anything.” Indeed, QOL scores usually have no meaning to practitioners. Although a level of 210 mm Hg is instantly recognized as high blood pressure, doctors have no guidelines to judge whether a QOL score of 78 points is significantly different from a score of 65. Thresholds are necessary to allow such judgments. Thresholds stratify continuous data into qualitatively distinct areas, such as good/ bad, low/high, or acceptable/unacceptable. With this process, raw data gain meaning and may elicit corresponding behavioral responses. To justify a particular threshold value, it must have some kind of external validity. In medicine, many thresholds or classification systems have prognostic value and predict progression of a disease or length of survival. A particularly prominent example is the blood pressure level. It is commonly assumed that 140/90 is an acceptable value at the high end of the scale. Values higher than that are regarded as “high blood pressure,” which may lead to cardiovascular events (stroke, heart attacks) and, therefore, deserve medical attention and/or treatment. However, the Hypertension Optimal Treatment randomized trial [26] suggests that the diastolic level of 90 may be too high. The occurrence of major cardiovascular complications was lowest in a group of patients with a mean diastolic blood pressure of 83. The debate on optimal levels of blood pressure and their generalizability across the general population and specific groups of patients continues [27]. This example illustrates that threshold levels have an “expiration date.” New empirical evidence on critical external criteria may result in the adaptation of threshold levels. At the moment, QOL assessment faces the problem that there is no empirical foundation on which threshold values can be based. Therefore, we have to interpret threshold criteria on a logical basis and prepare them for empirical testing. The basis of our reasoning is that the best known QOL questionnaires [20,28] display their scores on scales that range from 0 (very bad) to 100 (very good). A simple and intuitive approach is to set the partition in the middle of the scale (50-score point criterion) and regard values less than 50 as “unacceptably low.” In the case of the EORTC questionnaire, this reasoning can be justified as follows: ● The EORTC QOL questionnaire items tap into a patient’s degree of impairment, and answers can be given on 4-level response scales (1 ⫽ not at all, 2 ⫽ sometimes, 3 ⫽ quite, 4 ⫽ very much so). Responses can be easily dichotomized, and, by face validity, values 3 and 4 constitute the “bad” side, and 1 and 2 the “good” side [29]. ● According to psychologic theories on adaptation level and social comparison, persons generally try to per-
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form (slightly) better than average [30]. From this conception, values less than average (i.e., 50) are undesirable. It would be the goal of therapy to enable patients to score higher than 50. ● However, a therapeutic goal of 100 score points is not feasible from a health economic standpoint and also exceeds published norm reference values. ● Furthermore, an optimal score of 100 in overall happiness is not necessarily desirable all the time. Highest levels of affect intensity involve excesses in emotional arousal, that may be burdensome, distracting, and even pathologic [31]. We are aware that several criticisms can be held against our reasoning. One may argue that a uniform threshold level of 50 cannot be used because the individual QOL scores are based on a different numbers of items (from 2⫺5 in the case of multiple item scores), have different distributions (normal distribution, skewness), or vary in their content (e.g., pain is qualitatively different from physical functioning). Statistically more refined methodologies are conceivable that consider the distribution of the scores and norm reference values. However, such an approach faces the problem that norm reference values vary, depending on sex and age, and also show considerable cross-cultural variation [5,6,32]. Whatever method is used to determine a threshold level, there are 2 major potential pitfalls. If the threshold level for intervention is too low (0 ⫽ bad, 100 ⫽ good), patients who need help (because a scale value of 60 already indicates considerable symptom burden) may be missed. On the other hand, if the threshold level is too high, patients who are diagnosed as having an impaired QOL, when in reality they feel fine, may feel stigmatized. It would be desirable that such a test is both sensitive and specific. Unfortunately, there is no such test. The reason is that the setting of the threshold changes sensitivity and specificity in a reciprocal manner. Changing the cutoff point will increase sensitivity and lower specificity, or the other way round [33]. Therefore, the value judgment has to be made as to what properties a given test should have. It is generally assumed that a highly sensitive (correct positive) test is required when the goal is to identify a significant medical condition that can be appropriately treated at the cost that also healthy persons are identified and eventually treated. A specific (correct negative) test is required when diagnosis and therapy have severe side effects, and, therefore, maximum certainty is required that a positively diagnosed patient really has the condition [33]. The definition of QOL values that are objectively “normal” or “abnormal” is unrealistic [34]. Therefore, our central argument is that thresholds regarding QOL scores must be embedded in clinical reality. As argued previously, confounding factors such as the patient’s overall condition, comorbidity, time of assessment, critical scores values on
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other dimensions, or psychosocial variables have to be considered. Furthermore, numerous critical questions have to be considered. What is the goal of the therapy? What QOL score level is attainable? What is good QOL in this particular setting? How much is the health care system willing to pay for increases in QOL? Which therapy options are instrumental for improving QOL? Answers to these critical questions help to decide the usefulness of threshold levels. It is useless to specify threshold levels for symptoms that are transitory in nature, cannot be relieved, or require therapies that are not being covered by the health care system and are not accepted by patients. In the next section we describe a diagnostic system that is oriented toward these critical issues and interprets QOL threshold values in a broader clinical context to arrive at therapeutic recommendations.
QOL assessment: Integrative, clinically meaningful, and action oriented The next step is to make QOL “visible.” Doctors are used to obtaining patient information using various visual stimuli (e.g., x-ray, electroencephalogram, fever curves). This visual orientation is backed up by studies on human information processing [35,36]. It has been argued that the sheer improvement in the presentation of medical records leads to improvements in medical performance [37]. Therefore, QOL diagnostics have to meet this requirement, and that is why we have proposed the format of QOL profiles [38]. Our technique works as follows: a patient’s responses to the EORTC questionnaire items (50⫺60 in total; 30 items core questionnaire, 20⫺30 additional symptom/disease specific module) are being transformed into QOL scores. Corresponding individual items of the EORTC questionnaire are aggregated and then linearly transformed into a 0⫺100 point scale, 0 representing the worst outcome and 100 the optimum. A comprehensible number of scores (n ⫽ 10) [36] is then arranged vertically, and individual patient data can be read like any other information in the medical record. A computer program has been produced to create and print such profiles [39]. Fig. 2 illustrates a patient example from the Marburg rectal cancer study [40,41]. The QOL profile of this 55-year-old patient who underwent bowel resection for rectal carcinoma shows impairment in role functioning and stoma related problems. Although anastomotic leakage was documented as a complication during the early postoperative period, individual symptoms reported by the patient 8 months after operation were worse than expected. On the basis of the QOL profile and the patient’s medical history, consultation of a urologist and a stoma therapist were recommended. In a large study on patients with breast cancer at the Tumor Centre Regensburg [42,43], a system of QOL diagnostics has been established and is being tested in a randomized study [44]. More than 150 profiles have been
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Implementation and therapy options
Fig. 2. QOL profile of a patient with rectal cancer with urologic problems (post-op ⫽ postoperative). (Color version of figure is available online.)
produced so far. In line with the aforementioned proposed arguments, the 50-score point criterion has been used as a diagnostic anchor but has been qualified by considering the following aspects: time of assessment, comorbidity and co-fatality (e.g., acute problems in private life), family status, repeated measures, therapy at assessment and planned therapies for the future, and doctor evaluations and notes. For instance, immediately after the patient’s dismissal from the hospital, QOL values less than 50, particularly in the emotional domain, are not unusual and generally elicit no therapeutic action. We usually recommend a QOL control after 3 months. An exception would be high levels of arm-shoulder problems and pain after axillary dissection, and physiotherapy or pain therapy is not planned. In this case, the recommendation would be to start appropriate therapy immediately. A particular problem occurs when critical values are obtained in 3 or 4 QOL scores. In these cases, the profile fails to inform whether there is a main complaint that also affects the other QOL areas. It would make little sense to refer the patient to 3 of 4 different specialists. Therefore, we would recommend that the coordinating physician try to identify the central problem while talking to the patient. There is a panel of 5 five experts who are involved in this diagnostic process (clinicians, psychologists, and methodologists), which guarantees that no information is lost, and that all data are being discussed and integrated. The final decision is reached by consensus. The 50-score point is one important aspect but not the only one that would lead to a QOL diagnosis and corresponding therapeutic recommendation. Reports containing specific therapy options are sent to the attending doctors, and improvements in QOL can be obtained in the subsequent QOL assessment. The viability of the approach is currently rigorously tested in a randomized study. The hypothesis is that patients assigned to the QOL profile group have an advantage.
QOL profiles are useful diagnostic tools only when doctors are being made familiar with them and are able to make use of this information properly. Most practitioners have only a vague idea what the scientific meaning of QOL is. QOL is often mixed up with “wellness,” a term nowadays affecting almost all areas of life. However, when it comes to routine medical treatment, QOL has no role as a diagnostic category or as an endpoint of treatment. A key measure to overcome this problem is “implementation.” Implementation is the stepwise introduction and provision of information and behavioral skills to change the knowledge behaviors of addressees [45]. Evaluation research in the context of clinical practice guidelines showed consistently that singular approaches, such as dissemination, publication, or single teaching courses, are not effective to change a clinician’s mind and behavior [46]. Implementation works only with a continuing process of multiple strategies [47]. In the Marburg project [48], we combined quality circles, opinion leaders, and outreach visits as implementation techniques. These strategies are now being used in the ongoing Regensburg project [49]. A clinical pathway was generated that depicts the route from QOL assessment via diagnostics to informing practitioners and initiating QOL improving therapies. Both the Marburg and Regensburg projects have been using 5 therapy options to improve QOL for patients with breast cancer: (1) pain relief and therapy, (2) physiotherapy, (3) psychotherapy, (4) improving physical fitness (sports and nutrition), and (5) social rehabilitation. These options were also mentioned and evaluated in the Australian guidelines for the psychosocial care of patients with cancer [50]. One important role of the quality circle has been to identify competent specialist for the different therapeutic options and specify standards of care. This process is crucial because QOL improvements only can be achieved when the therapies are effective. So far, our experiences with QOL assessment and diagnostics are promising. Patients accept the questionnaires and are pleased that they contain issues that are important to them. Doctors found the profile easy to understand, and more than half stated that the profile led to more information and better communication [48].
Conclusions It is counterproductive to get caught up in never ending discussions on what QOL is and whether it can be assessed. This article is based on the idea that it is much more important to improve the conceptual frameworks that allow the use of the QOL concept in the clinical practice. It is obvious to predict that the “survival chances” of the QOL concept within the medical community will depend on its contributions to a better understanding of patients and to
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improve patient care [51]. One important lesson to be learned is that QOL should not be viewed in isolation. The concept is intimately related to other psychologic concepts but also to many external variables. Therefore, we strongly advocate a synthesis of basic sciences, such as social psychology, with QOL and clinical reality. QOL data should be presented in a way that is easily accessible for clinicians. The suggested profile format here visualizes deficits in particular QOL domains and allows action to be taken immediately. However, the reasons why a particular deficit exists cannot always be seen directly from the profile. Here, information regarding the medical history, basic psychologic variables, and the patient’s personal situation are necessary. A patient’s self-reports and his/her overall condition have to be explored so multiple perspectives can be gained [52]. In other words, a QOL profile is not a substitute but a starting point for a patient-doctor interaction. A profile driven interaction has the potential to be structured, efficient, and leading to action. The effect of this action then again can be tested empirically. When evidence concludes that QOL diagnostics indeed improve patient care, this is the best rebuttal against statements like “Scientists may use rating scales and visual analogue scales to measure pain, and they may even invent scoring systems quantifying types of handicaps, but when they talk about measuring quality of life, they have gone too far” [53].
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Seminar article
Outcome and quality of life in medicine: A conceptual framework to put quality of life research into practice Michael Koller, Ph.D.a,*, Monika Klinkhammer-Schalke, M.D.b, Wilfried Lorenz, M.D.b a b
Institute of Theoretical, Philipps-University, Marburg, Germany Tumor Centre, University of Regensburg, Regensburg, Germany
Abstract It is rather counterproductive to get caught up in never ending discussions on what quality of life (QOL) is and whether it can be assessed. This article is based on the idea that it is much more important to improve the conceptual frameworks that allow the use of the QOL concept in clinical practice. Survival of the QOL concept within the medical community will depend on its contributions to a better understanding of patients and to improving patient care. It is important to accept that QOL should not be viewed in isolation but in synopsis, with other psychologic concepts and clinical data. We propose a profile format that presents QOL data in a way that is easily accessible for clinicians, allowing action to be taken immediately. QOL profiles are never a substitute but a starting point for a patient-doctor interaction. A profile driven interaction has the potential to be structured, efficient, and leading to action. © 2005 Elsevier Inc. All rights reserved. Keywords: Quality of life; Clinical practice; Integrated outcome model
Introduction Problems with traditional concepts of health and quality of life A major issue of debate in quality of life (QOL) research today is the clinical relevance of QOL information. What does QOL mean in a clinical setting, and what are clinically meaningful QOL differences/changes? Is a value of 48 (on a scale of 0⫺100) good or bad QOL? Is a change from 48 to 61 an important improvement in a patient’s condition? Various efforts were made to settle these and related issues: computerized QOL assessment with subsequent information of doctors [1]; identification of score changes that patients perceive as minimally important [2]; identification of clinically relevant effect sizes by using statistical procedures [3,4]; and comparison of an individual’s QOL score with normal reference scores [5,6]. Our concern is that these suggestions are either too technical or too statistical and fail to consider that the kernel M.K. was supported by a BMBF-grant 01GT0303 (Pflegeforschungsverbund Mitte-Süd). The work described in this article was funded in part by a grant from the Bavarian Ministry of Health (“Bayern aktiv”). * Corresponding author. Tel.: ⫹49-6421-2862250; fax: ⫹49-64212868926. E-mail address: [email protected] (M. Koller). 1078-1439/05/$ – see front matter © 2005 Elsevier Inc. All rights reserved. doi:10.1016/j.urolonc.2005.03.002
of many problems lies in the conception of QOL as such. This can easily be illustrated with 2 World Health Organization (WHO) definitions, which have served as the starting point of most subsequent QOL definitions in medicine [7]. WHO definition of health Its definition is: “A state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.” WHO definition of QOL The definition is: “Quality of life is defined as an individual’s perception of their position in life in the context of the culture and value system in which they live and in relation to their goals, expectations and standards and concerns. It is a broad ranging concept affected in a complex way by the person’s physical health, psychological state, level of independence, social relationships, and their relationship to salient features of their environment.” These definitions are encompassing and idealizing and, consequently, are totally impractical from a clinical point of view. Which doctor would be able to “treat” the cultural context of his/her patients? Can the complete absence of disease really be an achievable treatment goal in a clinical
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setting? It is obvious that merely technical or statistical improvements, such as computer-aided diagnosis or the specification of effect sizes, are hardly helpful to answer such questions. Very clearly, numerous conceptual steps are necessary to make the QOL concept suitable for the clinical arena. Our approach is based on the following 4 premises: (1) a concept of disease related QOL; (2) the definition of thresholds, allowing to distinguish between acceptable QOL and unacceptable symptom burden requiring action; (3) the availability of comprehensible and action-oriented QOL diagnostics; and (4) implementation of the QOL concept/diagnostics into routine patient care and the availability of effective therapeutic options. Fig. 1. Three-component outcome model.
Integrating the medical paradigm and disease-related QOL: A 3-component outcome model As a first step, the role of QOL in the context of more accessible classical endpoints has to be clarified. QOL is not a surrogate or a competitor with traditional endpoints, such as survival, complication rates, or length of hospital stay. Moreover, when assessed in patients, QOL is not related to health (as is suggested by the term “health-related” QOL) but is rather related to a particular disease. The psychologic situation and, consequently, the concept of QOL of ill people are different from “healthy” or “normal” people. Differences exist in a number of aspects: ● Patients possess an attribute that is socially and personally undesirable, namely an illness. ● They want to get rid of this condition, resulting in an avoidance orientation to get from one state to another. ● Patients have to enter (or are forced into) a particular social interaction with individuals that rank very high in the social hierarchy; patient’s emotional reactions to these individuals will be particularly high, and may range from helplessness to trust and hope. ● A patient’s physiologic/biologic state is different, alleviated levels of cytokines or killer cell activity may affect psychologic states and, as a consequence, questionnaire responses. ● Specific conditions (e.g., palliation) are outside the realm of “normal” everyday human experience, therefore, specific assessment instruments are necessary [8,9]. This viewpoint is very different from a “having fun” stereotype of a good QOL. The implication is that a patient’s QOL can only be understood in the context with his/her medical condition record. To be more specific, a patient is best described in terms of 3 components [10,11]: classical, mechanistic endpoints (survival, complication rates, laboratory parameters, imaging); patient-based or hermeneutic endpoints (QOL, expectations, stigma); and a value judgment in a functioning patient-physician relation-
ship to decide which of these possible measures is the most relevant one for a patient in a given clinical situation. The 3-component outcome analysis is necessary for recognizing the relations among the various endpoints and for defining an empirically derived hierarchy (ranking). The major distinction between the 2 halves of the faces in Fig. 1 is that the left half is physician-assessed, whereas the right half is reported by the patient himself/herself, based on personal perceptions, impression, feelings, and reactions. Furthermore, the 2 halves of the face reflect the fact that patient’s responses are not 1:1 related to objective health parameters. Numerous psychosocial variables play a role as investigated in various studies. Overall, somatic symptom distress was highly correlated with the psychologic variables “negative affect” (r ⫽ 0.70⫺0.75), “experienced social stigma” (r ⫽ 0.51), “social desirability” (r ⫽ ⫺0.50), and “positive thinking” (r ⫽ 0.40 or ⫺0.40, depending on whether positive affect or compensatory selfrelated positive thinking was dominant) [12–14]. A comparable pattern of results was observed when these variables were correlated with global QOL as the quasi-dependent variable. However, both somatic symptoms and global QOL were practically unrelated to objective clinical criteria (tumor growth, findings of imaging techniques, carcinoembryonic antigen level, and external physician’s overall judgments) [12–14]. In summary, it becomes clear that QOL is a domain outside the mechanistic viewpoint of the biochemical/molecular biologic paradigm. Therapy related expectations were investigated in a study of patients with cancer undergoing radiotherapy [15]. Although most patients had advanced forms of cancer and they were treated according to a palliative therapeutic regimen, almost 2 of 3 expected a cure from therapy. Although all patients had been fully informed, many of them would not give up healing expectations. Psychologic processes like these are discussed in the literature under the labels “positive illusions” [16] and denial [17]. The corollaries of therapy related expectations were remarkable: patients who
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expected a cure had a significantly better QOL before therapy, but those who expected pain relief had a significantly worse QOL. However, when patients realized that their expectations were not fulfilled, they had particularly low levels of QOL after therapy [15]. Thus, expectations apparently go into 2 fundamentally different directions, good or bad QOL. For clinical purposes, we have to know for individual patients what their expectations are like. When asked which outcome was most important to them, patients who were about to undergo cholecystectomy [18] had a strong preference for items such as “to regain physical fitness as quickly as possible” or “to become the same as before the disease.” This result was extremely surprising, as in none of the more than 60 studies comparing laparoscopic and open cholecystectomy, the return-to-physical-fitness variable has been the primary endpoint: cosmetics and low levels of pain were considered to be most important. Because many of these trials had high methodological standards (prospective, randomized) and used reliable and valid outcome measures, their findings are considered to be formally correct. However, it is likely that these studies have assessed correctly the wrong issue, namely, outcomes that were more important to doctors than to the affected patients. Several questionnaires (European Organization for the Research and Treatment of Cancer [EORTC], RAND 36Item Health Survey) allow for a person’s overall judgment of QOL [19,20]. This overall judgment must not be confused with the aggregation of a summary score across different QOL components, as preferred by other questionnaire approaches [21,22]. On the level of individual patients, clinical experience teaches that some patients who have considerable health problems, which they also openly admit, still rate their “overall” QOL as relatively good. On the level of larger scale patient samples, regression analyses show that objective health parameters and self-reported health variables do not fully explain the variance of global QOL [12,13]. Furthermore, it has been shown repeatedly that individuals often report relatively high levels of QOL, despite the fact that their health is severely impaired. A particularly well-known and dramatic example was described by Brickman et al. [23], who found that after a certain adaptation period, paraplegic accident victims and lottery winners reported practically the same average level of overall well-being. In the literature, this phenomenon is called “well-being paradox” [24]. It appears plausible that an overall judgment of QOL includes a component of coping, reflecting how well the patient can handle his/her life situation when facing a health problem [25]. In summary, these findings clearly show that QOL, as currently assessed in standardized questionnaires, is not an isolated concept but has to be regarded as one facet in a whole spectrum of variables. This notion is particularly important when it comes to diagnosing patients (see “QOL assessment: Integrative, clinically meaningful, and action oriented” section).
Thresholds: Distinguishing between acceptable QOL and unacceptable symptom burden A typical remark often expressed by QOL skeptics is: “We are aware of these questionnaires, but they did not change anything.” Indeed, QOL scores usually have no meaning to practitioners. Although a level of 210 mm Hg is instantly recognized as high blood pressure, doctors have no guidelines to judge whether a QOL score of 78 points is significantly different from a score of 65. Thresholds are necessary to allow such judgments. Thresholds stratify continuous data into qualitatively distinct areas, such as good/ bad, low/high, or acceptable/unacceptable. With this process, raw data gain meaning and may elicit corresponding behavioral responses. To justify a particular threshold value, it must have some kind of external validity. In medicine, many thresholds or classification systems have prognostic value and predict progression of a disease or length of survival. A particularly prominent example is the blood pressure level. It is commonly assumed that 140/90 is an acceptable value at the high end of the scale. Values higher than that are regarded as “high blood pressure,” which may lead to cardiovascular events (stroke, heart attacks) and, therefore, deserve medical attention and/or treatment. However, the Hypertension Optimal Treatment randomized trial [26] suggests that the diastolic level of 90 may be too high. The occurrence of major cardiovascular complications was lowest in a group of patients with a mean diastolic blood pressure of 83. The debate on optimal levels of blood pressure and their generalizability across the general population and specific groups of patients continues [27]. This example illustrates that threshold levels have an “expiration date.” New empirical evidence on critical external criteria may result in the adaptation of threshold levels. At the moment, QOL assessment faces the problem that there is no empirical foundation on which threshold values can be based. Therefore, we have to interpret threshold criteria on a logical basis and prepare them for empirical testing. The basis of our reasoning is that the best known QOL questionnaires [20,28] display their scores on scales that range from 0 (very bad) to 100 (very good). A simple and intuitive approach is to set the partition in the middle of the scale (50-score point criterion) and regard values less than 50 as “unacceptably low.” In the case of the EORTC questionnaire, this reasoning can be justified as follows: ● The EORTC QOL questionnaire items tap into a patient’s degree of impairment, and answers can be given on 4-level response scales (1 ⫽ not at all, 2 ⫽ sometimes, 3 ⫽ quite, 4 ⫽ very much so). Responses can be easily dichotomized, and, by face validity, values 3 and 4 constitute the “bad” side, and 1 and 2 the “good” side [29]. ● According to psychologic theories on adaptation level and social comparison, persons generally try to per-
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form (slightly) better than average [30]. From this conception, values less than average (i.e., 50) are undesirable. It would be the goal of therapy to enable patients to score higher than 50. ● However, a therapeutic goal of 100 score points is not feasible from a health economic standpoint and also exceeds published norm reference values. ● Furthermore, an optimal score of 100 in overall happiness is not necessarily desirable all the time. Highest levels of affect intensity involve excesses in emotional arousal, that may be burdensome, distracting, and even pathologic [31]. We are aware that several criticisms can be held against our reasoning. One may argue that a uniform threshold level of 50 cannot be used because the individual QOL scores are based on a different numbers of items (from 2⫺5 in the case of multiple item scores), have different distributions (normal distribution, skewness), or vary in their content (e.g., pain is qualitatively different from physical functioning). Statistically more refined methodologies are conceivable that consider the distribution of the scores and norm reference values. However, such an approach faces the problem that norm reference values vary, depending on sex and age, and also show considerable cross-cultural variation [5,6,32]. Whatever method is used to determine a threshold level, there are 2 major potential pitfalls. If the threshold level for intervention is too low (0 ⫽ bad, 100 ⫽ good), patients who need help (because a scale value of 60 already indicates considerable symptom burden) may be missed. On the other hand, if the threshold level is too high, patients who are diagnosed as having an impaired QOL, when in reality they feel fine, may feel stigmatized. It would be desirable that such a test is both sensitive and specific. Unfortunately, there is no such test. The reason is that the setting of the threshold changes sensitivity and specificity in a reciprocal manner. Changing the cutoff point will increase sensitivity and lower specificity, or the other way round [33]. Therefore, the value judgment has to be made as to what properties a given test should have. It is generally assumed that a highly sensitive (correct positive) test is required when the goal is to identify a significant medical condition that can be appropriately treated at the cost that also healthy persons are identified and eventually treated. A specific (correct negative) test is required when diagnosis and therapy have severe side effects, and, therefore, maximum certainty is required that a positively diagnosed patient really has the condition [33]. The definition of QOL values that are objectively “normal” or “abnormal” is unrealistic [34]. Therefore, our central argument is that thresholds regarding QOL scores must be embedded in clinical reality. As argued previously, confounding factors such as the patient’s overall condition, comorbidity, time of assessment, critical scores values on
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other dimensions, or psychosocial variables have to be considered. Furthermore, numerous critical questions have to be considered. What is the goal of the therapy? What QOL score level is attainable? What is good QOL in this particular setting? How much is the health care system willing to pay for increases in QOL? Which therapy options are instrumental for improving QOL? Answers to these critical questions help to decide the usefulness of threshold levels. It is useless to specify threshold levels for symptoms that are transitory in nature, cannot be relieved, or require therapies that are not being covered by the health care system and are not accepted by patients. In the next section we describe a diagnostic system that is oriented toward these critical issues and interprets QOL threshold values in a broader clinical context to arrive at therapeutic recommendations.
QOL assessment: Integrative, clinically meaningful, and action oriented The next step is to make QOL “visible.” Doctors are used to obtaining patient information using various visual stimuli (e.g., x-ray, electroencephalogram, fever curves). This visual orientation is backed up by studies on human information processing [35,36]. It has been argued that the sheer improvement in the presentation of medical records leads to improvements in medical performance [37]. Therefore, QOL diagnostics have to meet this requirement, and that is why we have proposed the format of QOL profiles [38]. Our technique works as follows: a patient’s responses to the EORTC questionnaire items (50⫺60 in total; 30 items core questionnaire, 20⫺30 additional symptom/disease specific module) are being transformed into QOL scores. Corresponding individual items of the EORTC questionnaire are aggregated and then linearly transformed into a 0⫺100 point scale, 0 representing the worst outcome and 100 the optimum. A comprehensible number of scores (n ⫽ 10) [36] is then arranged vertically, and individual patient data can be read like any other information in the medical record. A computer program has been produced to create and print such profiles [39]. Fig. 2 illustrates a patient example from the Marburg rectal cancer study [40,41]. The QOL profile of this 55-year-old patient who underwent bowel resection for rectal carcinoma shows impairment in role functioning and stoma related problems. Although anastomotic leakage was documented as a complication during the early postoperative period, individual symptoms reported by the patient 8 months after operation were worse than expected. On the basis of the QOL profile and the patient’s medical history, consultation of a urologist and a stoma therapist were recommended. In a large study on patients with breast cancer at the Tumor Centre Regensburg [42,43], a system of QOL diagnostics has been established and is being tested in a randomized study [44]. More than 150 profiles have been
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Implementation and therapy options
Fig. 2. QOL profile of a patient with rectal cancer with urologic problems (post-op ⫽ postoperative). (Color version of figure is available online.)
produced so far. In line with the aforementioned proposed arguments, the 50-score point criterion has been used as a diagnostic anchor but has been qualified by considering the following aspects: time of assessment, comorbidity and co-fatality (e.g., acute problems in private life), family status, repeated measures, therapy at assessment and planned therapies for the future, and doctor evaluations and notes. For instance, immediately after the patient’s dismissal from the hospital, QOL values less than 50, particularly in the emotional domain, are not unusual and generally elicit no therapeutic action. We usually recommend a QOL control after 3 months. An exception would be high levels of arm-shoulder problems and pain after axillary dissection, and physiotherapy or pain therapy is not planned. In this case, the recommendation would be to start appropriate therapy immediately. A particular problem occurs when critical values are obtained in 3 or 4 QOL scores. In these cases, the profile fails to inform whether there is a main complaint that also affects the other QOL areas. It would make little sense to refer the patient to 3 of 4 different specialists. Therefore, we would recommend that the coordinating physician try to identify the central problem while talking to the patient. There is a panel of 5 five experts who are involved in this diagnostic process (clinicians, psychologists, and methodologists), which guarantees that no information is lost, and that all data are being discussed and integrated. The final decision is reached by consensus. The 50-score point is one important aspect but not the only one that would lead to a QOL diagnosis and corresponding therapeutic recommendation. Reports containing specific therapy options are sent to the attending doctors, and improvements in QOL can be obtained in the subsequent QOL assessment. The viability of the approach is currently rigorously tested in a randomized study. The hypothesis is that patients assigned to the QOL profile group have an advantage.
QOL profiles are useful diagnostic tools only when doctors are being made familiar with them and are able to make use of this information properly. Most practitioners have only a vague idea what the scientific meaning of QOL is. QOL is often mixed up with “wellness,” a term nowadays affecting almost all areas of life. However, when it comes to routine medical treatment, QOL has no role as a diagnostic category or as an endpoint of treatment. A key measure to overcome this problem is “implementation.” Implementation is the stepwise introduction and provision of information and behavioral skills to change the knowledge behaviors of addressees [45]. Evaluation research in the context of clinical practice guidelines showed consistently that singular approaches, such as dissemination, publication, or single teaching courses, are not effective to change a clinician’s mind and behavior [46]. Implementation works only with a continuing process of multiple strategies [47]. In the Marburg project [48], we combined quality circles, opinion leaders, and outreach visits as implementation techniques. These strategies are now being used in the ongoing Regensburg project [49]. A clinical pathway was generated that depicts the route from QOL assessment via diagnostics to informing practitioners and initiating QOL improving therapies. Both the Marburg and Regensburg projects have been using 5 therapy options to improve QOL for patients with breast cancer: (1) pain relief and therapy, (2) physiotherapy, (3) psychotherapy, (4) improving physical fitness (sports and nutrition), and (5) social rehabilitation. These options were also mentioned and evaluated in the Australian guidelines for the psychosocial care of patients with cancer [50]. One important role of the quality circle has been to identify competent specialist for the different therapeutic options and specify standards of care. This process is crucial because QOL improvements only can be achieved when the therapies are effective. So far, our experiences with QOL assessment and diagnostics are promising. Patients accept the questionnaires and are pleased that they contain issues that are important to them. Doctors found the profile easy to understand, and more than half stated that the profile led to more information and better communication [48].
Conclusions It is counterproductive to get caught up in never ending discussions on what QOL is and whether it can be assessed. This article is based on the idea that it is much more important to improve the conceptual frameworks that allow the use of the QOL concept in the clinical practice. It is obvious to predict that the “survival chances” of the QOL concept within the medical community will depend on its contributions to a better understanding of patients and to
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improve patient care [51]. One important lesson to be learned is that QOL should not be viewed in isolation. The concept is intimately related to other psychologic concepts but also to many external variables. Therefore, we strongly advocate a synthesis of basic sciences, such as social psychology, with QOL and clinical reality. QOL data should be presented in a way that is easily accessible for clinicians. The suggested profile format here visualizes deficits in particular QOL domains and allows action to be taken immediately. However, the reasons why a particular deficit exists cannot always be seen directly from the profile. Here, information regarding the medical history, basic psychologic variables, and the patient’s personal situation are necessary. A patient’s self-reports and his/her overall condition have to be explored so multiple perspectives can be gained [52]. In other words, a QOL profile is not a substitute but a starting point for a patient-doctor interaction. A profile driven interaction has the potential to be structured, efficient, and leading to action. The effect of this action then again can be tested empirically. When evidence concludes that QOL diagnostics indeed improve patient care, this is the best rebuttal against statements like “Scientists may use rating scales and visual analogue scales to measure pain, and they may even invent scoring systems quantifying types of handicaps, but when they talk about measuring quality of life, they have gone too far” [53].
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