Over the past two decades, there has been an increasing focus on quality of life outcomes in urological diseases. For most of this time, patient-reported outcomes research has relied on brief, structured assessments that constrain interpretation of the impact of disease and treatments on patients' quality of life. With the advent of alternatives for surgical reconstruction, bladder cancer patients face difficult choices and considerable uncertainty involving the long-term impact of treatment on lifestyle and activities. As such, it is necessary to understand treatment outcomes in light of particular patients' actual concerns and experiences. In this study, we introduce a new assessment procedure intended to provide perspective on individuals' priorities, based on Rapkin and Schwartz' (2004) quality of life appraisal model. This assessment is intended to complement standard measures of health-related quality of life (HRQOL), in order to distinguish differences in outcomes among patients with different priorities. In the present study we report results of a content analysis and psychometric evaluation of this Quality of Life Appraisal Profile, as prelude to a prospective comparison of outcomes of different reconstructive procedures for invasive bladder cancer.
HRQOL encompasses an array of patient-reported outcomes and can be defined as a patient's evaluation of the impact of a health condition and its treatment on all relevant aspects of life. HRQOL research on patients with bladder cancer is urgently needed, as bladder cancer is the fifth most commonly diagnosed cancer with an estimated 70,980 new cases in 2009 in the USA alone. It is the second most common malignancy of the genitourinary tract. It is the fourth most common malignancy in males, and the 11th in females . Patients treated with radical surgery undergo one of three options for urinary diversions; ileal conduit urinary diversion, neobladder, or continent reservoir. The decision of the type of urinary diversion depends on surgeons experience and patient's performance status and comorbidities, in addition to patient's preference. Each of these reconstructive techniques carries different benefits and risks, and requires patients to exercise different self care skills.
QOL studies will help to fully articulate the impact of the different treatment modalities beyond survival rates, define levels of intervention in daily patient care, and point to factors that most significantly affect QOL in this specific setting (e.g., by selecting the optimal form of urinary diversion in the individual case or identifying a subset of patients who are likely to benefit in their adjustment by psychosocial intervention). In addition, bladder cancer is ranked as the most expensive common adult cancer in average health care costs incurred per patient from diagnosis to death in the United States. Thus, quality of life impacts are an important consideration in evaluating comparative effectiveness of treatments and controlling quality in these times of increasing costs, resource constraints, and priority setting within the health care market .
Existing quality of life measures provide a starting point for describing patients' experience of illness, treatment, and survivorship. Available standard assessments ask patients to rate their general quality of life in several domains (physical and emotional well-being, pain and symptoms, activities of daily living, role functioning, social activity, overall health) [3, 4]. There are also standard rating scales to cover domains and problems of specific concern to bladder cancer patients: urinary, bowel, and sexual functioning [5–8]. More recently, scales have been introduced to examine treatment-specific questions such as adaptation to stomata, incorporation of lifestyle, activity or dietary changes, and stress and anxiety associated with watchful waiting [9, 10, 2, 11]. Such rating scales are widely accepted and used, and considerable normative data are available, especially pertaining to general aspects of cancer-related quality of life and functioning .
Generic or global HRQOL instruments are applied across different diseases, conditions, populations, and concepts. Examples of generic instruments are the SF-36, the Quality of Well-Being scale, and the Sickness Impact Profile (SIP) [13–15]. Each of these instruments has undergone extensive developmental testing and is considered a valid measure. However, these measures may lack the specificity and sensitivity needed to capture relevant changes related to HRQOL specific to cancer patients .
Cancer-specific instruments attempt to measure HRQOL as it pertains to cancer treatment. This specificity leads to more narrowly-focused sets of items that may make them less likely to detect unanticipated effects. Two examples of cancer-specific measures are the European Organization for Research and Treatment of Cancer-QOL (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy general form (FACT-G) [17, 3]. These cancer-specific measures also include cancer site- or treatment- specific modules to further address unique concerns. Currently, there are few site-specific instruments that measure HRQOL in bladder cancer patients who require cystectomy and urinary diversion. Two examples are the FACT-BL and the EORTC QLQ-BLM30 (the latter is still under development). In 2003, Cookson reported the results of an initial validation study of a bladder cancer-specific instrument, the Vanderbilt cystectomy index (FACT-VCI) .
Over the past two decades there have been several major studies comparing HRQOL for patients undergoing radical cystectomy and urinary diversion. However, these studies were limited in several significant ways. In a selective review of 15 more recent studies by Porter and Penson, ten used some type of previously validated health related HRQOL instrument and five used bladder cancer disease specific instruments only, five used general instruments only (not specific to bladder cancer), and five studies used a combination. However, only one of the bladder cancer disease specific instruments was validated in previous studies (FACT-Bl). These instruments were administered at different time points after surgery, usually in a single mailing or a single session in the clinic after radical cystectomy. Only one of the studies included a pre-operative baseline evaluation.
Based on findings from general QOL instruments, most of these studies concluded that patients who have recovered from a radical cystectomy generally report a high HRQOL, not significantly different than people of similar age in the general population. Thus, despite the magnitude of the surgery and the degree of change in a major organ function, patients who recover from surgery and are cured appear to maintain or regain their HRQOL . However, it is possible that these general measures are not sensitive to issues of unique importance to bladder cancer patients. More specifically, serious limitations affect the utility of standard HRQOL measures for understanding adaptation to bladder cancer. These limitations can be summarized in three ways:
Lack of coverage of key domains of concerns: Concise scales designed to be used in a wide variety of situations may miss important aspects of well-being or adjustment among certain patients or during certain periods of illness and recovery. For example, although patients may rate that they have little problem with urinary frequency, information may be missing about restrictions of activity, difficulties with use of pads, or occasional embarrassing situations that are having great impact on their quality of life.
Individual differences in experiences, values, and priorities: Ratings of standard scales do not take into account people's different interpretations and frames of reference. Such cognitive differences in appraising QOL may lead people to respond to items in ways that markedly affects the comparability of their responses. For example, when asked to rate difficulty in functioning, some individuals will compare their current status to past performance; others will make comparisons with other patients; still others will base ratings on what they expected or imagined when they heard the term "cancer". These individual differences may even enter into the meaning and interpretation of items: "satisfaction with role functioning" means something very different for people who want or expect to return to work versus people who want or expect to scale back. Comparison of individual differences in quality of life ratings requires some understanding of the personal context and meaning underlying these ratings, especially in heterogeneous patient populations.
Intra-individual "response shifts" in the appraisal of quality of life measures: Over the course of life-threatening illness, individuals may change their perspectives and expectations regarding quality of life. Such changes in perspective affect in turn the measurement of changes in HRQOL, including changes associated with the benefits of treatment. For example, immediately after completion of treatment, patients may base their ratings of fatigue and energy level on the immediate circumstances of their illness and recovery. Several months later, ratings of the same scales may reflect shifting expectations for greater stamina and a desire to return to a "normal" level of activity. Energy may have improved markedly, but changing expectations may mask this improvement or even indicate a decline.
These problems in measurement are not insurmountable. Rapkin and colleagues have developed a number of measurement approaches intended to complement standard measures of quality of life by eliciting differences and changes in patients' concerns, standards of comparison, and priorities for quality of life [19–22]. These "idiographic" (i.e., self-written) measures provide a way to gain better understanding of the meaning that patients impart to different scales, and to take this information into account in the evaluation of effects associated with illness and treatment. The rational behind this measure stems from the theory that comparable measures of aspirations (i.e. goals) are needed to fully evaluate individual's personal views of wellbeing. To achieve these ends, the goals elucidated must be compared in terms of the individual's own ideas of life satisfaction . The model was recently validated in a sample of cancer survivors by Bloem and colleagues . Li and Rapkin (2009) report an analysis of the association of changes in personal goals and changes in quality of life, among people living with HIV/AIDS, using idiographic data from the HIV Choices in Care Study . They found that both positive and negative changes in quality of life ratings as well as apparent stability of ratings are each related to several distinct patterns of change in quality of life appraisal, even after controlling for demographic variables, baseline quality of life, and ensuing changes in clinical status and treatment.
Other previous studies have included idiographic measures of HRQOL, most notably, the Schedule for the Evaluation of Individual Quality of Life (SEIQOL). The SEIQOL is designed to capture between three and eight "cues" that fall in one of the generally agreed upon QOL domains of CASPER model - Cognitive, Affective, Social, Physical, Ecological and Religious domains. The respondent then rates his or her satisfaction with current functioning in regard to each personal statement on a 0-10 scale; and, then the relative importance of each cue is explored by having the individual rank his or her expected enjoyment of 30-50 hypothetical individual cases . However, this approach relies heavily on individuals' interpretation of CASPER domains. Further, this approach is limited to a maximum of eight responses. We used the Rapkin and Schwartz (2004) approach to permit a wider variety and number of responses to emerge, and to allow individuals to directly evaluate their progress toward attainment of each identified personal goal .
This paper will describe the characteristics of the Quality of Life Appraisal Profile and discuss our system for coding patients' personal goals and motivational themes. We will then examine preliminary psychometric properties and validity of the QOL Appraisal Profile in the bladder cancer population, including associations with patient demographic and standard HRQOL measures. This descriptive measurement study is intended to set the stage for using this measurement in a large, prospective evaluation of changes in HRQOL associated with different surgical reconstruction procedures following radical cystectomy for bladder cancer.