The purpose of this review was to systematically identify and evaluate patient-reported outcome measures used for assessing HRQOL in men diagnosed with prostate cancer and to make recommendations about these outcome measures based on psychometric properties and clinical utility. The outcome measures reviewed by the Prostate Cancer EDGE Task Force members comprised (1) prostate cancer–specific HRQOL measures, (2) general cancer HRQOL measures, and (3) general HRQOL measures. Seven measures received the highest score possible (4) on the rating scale and were therefore favorably recommended by the reviewers.
The EPIC is a 50-item instrument designed to evaluate patient function and bother after prostate cancer treatment. It evolved from the original UCLA-PCI via expert panel and patients with localized prostate cancer.36 The questionnaire assesses 4 domains (urinary, bowel, sexual, and hormonal) using a 4- to 5-point Likert scale. The questionnaire is comprehensive and contains additional items missing from the UCLA-PCI such as irritative and obstructive voiding symptoms, hematuria, and hormonal symptoms.36 The EPIC exhibits good internal consistency and test-retest reliability; it has strong correlations with other prostate cancer–specific instruments and is widely used both clinically and in research.36, 38, 39 Combining the EPIC with a general HRQOL instrument such as SF-36 or SF-12 allows for a broader assessment of HRQOL and ability to distinguish between primary prostate cancer and progression, as well as for HRQOL effects of different prostate cancer treatment regimens.35, 40 The EPIC takes some time to complete, and scoring is not intuitive, so there is a shorter version of 26 items, as well as a clinical practice version with 16 items. The EPIC-26, in fact, has undergone extensive reliability and validity testing and might be a better option to use clinically because it is shorter.40, 41
The Functional Assessment of Cancer Therapy–Prostate (FACT-P) is a combination of the FACT-General (FACT-G) plus a 12-item prostate cancer–specific supplement or subscale (PCS). The PCS includes questions related to pain, appetite, sexual function, and urinary and bowel functions. Good psychometrics have been reported for both the FACT-P and the PCS and is able to discriminate between patients at different stages of disease, prostate-specific antigen levels, and performance status.42, 43 A clinically meaningful change of 6 to 10 points for the FACT-P total score and 2 to 3 points for the PCS has been reported.44 The FACT-P has been used extensively both clinically and in research. It is relatively easy to use and requires little training for staff or clinicians to administer and score; however, the questionnaire is relatively lengthy. A shorter general HRQOL such as SF-8 or SF-12 to supplement the PCS might lessen response burden.
The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) was designed to be multidimensional across multiple cancer diagnoses and cultural settings.45 The current version (version 3.0) has 30 items, measuring 5 functional scales (Physical, Role, Cognitive, Emotional, and Social), 3 symptoms scales (fatigue, pain and nausea/vomiting), and 3 global health and QOL items.46 The QLQ-C30 is intended to be supplemented by additional subscales that assess additional aspects of particular importance to specific patient subgroups, to increase the ability of the instrument to detect clinically meaningful differences in quality of life over time.47 The QLQ-PR25 is an example of such a subscale that can be used with the QLQ-C30. Although originally developed to assess HRQOL of patients in research clinical trials,48 the QLQ-C30 has often been used in clinical situations. Numerous studies have provided strong support for its reliability and validity, as well as clinically meaningful change.49–51 It is relatively easy to use and has been translated in several languages. The scoring for the questionnaire can be rather complex, but the scoring system is outlined in the available scoring manual. For the prostate cancer population, it is recommended that the QLQ-C30 be used with the QLQ-PR25.
The Functional Assessment of Cancer Therapy–General (FACT-G) was designed to assess the HRQOL of patients with any stage and form of cancer, but without cognitive or psychological disease.52 It has been translated into several languages and has been validated for specific cancer subgroups, including metastatic prostate cancer.53 The current version (version 4) has 27 items with questions covering 4 subscales—Physical Well-being, Social/Family Well-being, Emotional Well-being, and Functional Well-being.52 Responses are scored on a 5-point Likert scale, where the higher the score, the better the quality of life. The FACT-G has been extensively tested and validated; minimally important differences as well as normative data have been reported, which allows for increased confidence in clinical decision making.52, 54–58 A shorter version, the FACT-G7, with only 7 items has been developed to ease response burden.59 In instances where the clinician or researcher is more interested in experiences or quality of life specifically related to patients with prostate cancer, the use of the FACT-P might be a better option than the FACT-G.
The SF Health Surveys assess non–condition-specific functional health and were originally validated in patients with chronic conditions, including cancer.60 The original SF survey had 36 items; shorter versions, the SF-8 and SF-12, have been consequently developed to decrease response burden while retaining the psychometric properties of the instrument.60–62 Each SF survey measures 8 domains: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. The SF surveys have shown strong psychometric properties, have been translated in multiple languages, and have established MCID data.60–63 These instruments are widely reported in cancer literature, including many studies evaluating quality of life for patients with prostate cancer, although specific validation in this population has not been reported.
The reviewers were unable to recommend 13 of the reviewed outcome measures at this time. Five of these measures, the EQ-5D, HUI (Health Utilities Index), Quality Well-being, Rotterdam Symptom Checklist, and WHOQoL, are generic measures of quality of life that have been reported in very limited studies in the prostate cancer literature. There is also insufficient information on responsiveness to change and items pertaining to issues specific to prostate cancer, which limit its utility in clinical decision making.
Three measures, CARES (Cancer Rehabilitation Evaluation System), QLI-CV (Quality-of-Life Index–Cancer Version), and FLIC (Functional Living Index Cancer), have all been developed for use with cancer patients. However, while some of these measures have been used in studies with patients with prostate cancer, it has not been specifically validated in this population. Moreover, in the instance of the CARES, the length of the instrument and complexity of scoring may make it difficult to administer, which limits its clinical utility.
There are several factors that should be considered when interpreting the Task Force recommendations. An outcome measure may have been excluded in this review because of a lack of published data; the authors are aware that new studies may have been published after August 2013. For measures that could not be recommended at this time, additional information may become available that might elevate the Task Force recommendation in the future. The literature search was limited to English-language journals. Therefore, journals in other languages were not reviewed, which may have limited the number of quality-of-life measures that could have been reviewed. Researchers and clinicians are encouraged to review the Task Force recommendations, as well as each specific outcome measure for more extensive information. While the findings from this review can serve as a guide, ultimately, it is up to the clinician and the researcher to identify the best available evidence in addition to patient values and expectations in order to appropriately administer the correct quality-of-life outcome measure.64
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