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Oncology Section EDGE Task Force on Prostate Cancer

A Systematic Review of Outcome Measures for Health-Related Quality of Life

Harrington, Shana, PT, PhD, SCS, MTC1; Lee, Jeannette, PT, PhD2; Colon, Genevieve, DPT3; Alappattu, Meryl, PT, DPT, PhD4

doi: 10.1097/01.REO.0000000000000004
RESEARCH-META ANALYSIS & SYSTEMATIC REVIEWS
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Background: Health-related quality of life (HRQOL) is multidimensional and subjective, encompassing occupational and physical function, psychological state, social interaction, and somatic sensation. Because of the wide scope of HRQOL and its implications for the medical management of prostate cancer survivors, clinicians and researchers need to know the most reliable and valid measures currently available for addressing this clinical construct in men diagnosed with prostate cancer.

Purpose: To identify and evaluate patient-reported outcome measures used to assess HRQOL in men diagnosed with prostate cancer and make recommendations for the use of these patient-reported outcome measures in both the research and clinic settings.

Methods: The literature was systematically reviewed for patient-reported outcome measures used in peer-reviewed, published research to assess HRQOL in men diagnosed with prostate cancer. The goals were to examine the psychometric properties of commonly used HRQOL measures in order to determine their clinical utility.

Results: The following patient-reported outcome measures are highly recommended by the Task Force to assess HRQOL in men diagnosed with prostate cancer: EORTC QLQ-P25 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Prostate 25), EPIC (Expanded Prostate Cancer Index Composite), FACT-P (Functional Assessment of Cancer Therapy–Prostate), UCLA-PCI (UCLA–Prostate Cancer Index), EORTC QLQ-C30 (EORTC Quality of Life Questionnaire–Cancer 30), FACT-G (Functional Assessment of Cancer Therapy–General), and SF (Short-Form) 36, 12, and 8.

Conclusions: A variety of patient-reported outcome measures have been reported in the literature to assess HRQOL in men diagnosed with prostate cancer. Seven measures were found to have satisfactory psychometric properties, as well as good clinical utility, and are recommended for use by the researchers on this Task Force.

1Associate Professor, Department of Physical Therapy, Creighton University, Omaha, NE

2Assistant Professor, UCSF/SFSU Graduate Program in Physical Therapy, San Francisco, CA

3Covenant Healthcare, Saginaw, MI

4Research Assistant Professor and K12 Scholar, Department of Physical Therapy, University of Florida, Gainesville, FL

Correspondence: Shana Harrington, PT, PhD, SCS, MTC, Department of Physical Therapy, Creighton University, 2500 California Plaza, Omaha, NE 68178 (ShanaHarrington@creighton.edu).

The authors declare no conflicts of interest.

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INTRODUCTION

Prostate cancer is the most common cancer affecting men in the United States, with an estimated 220 800 new cases in 2015.1 Currently, there are more than 2.9 million men in the United States who are prostate cancer survivors.1 Although the relative survival rate for prostate cancer is almost 100%,2 prostate cancer and its treatment continue to be associated with many undesirable symptoms and side effects including a decrease in health-related quality of life (HRQOL).3 For men diagnosed with prostate cancer, survival is often considered the most important decision factor regarding choice of intervention; however, quality of life may be equally important.4

Quality of life is a broad multidimensional concept that examines physical, social, and psychological functioning.5 The World Health Organization defines quality of life as an “individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept affected in a complex way by the persons' physical health, psychological state, level of independence, social relationships and their relationship to salient features of their environment.”6(p1) Quality of life is challenging to measure because although the term “quality of life” has meaning for nearly everyone, including those in academics, individuals, and groups, can and often define it differently.7 Health-related quality of life is a subset of quality of life, with a number of definitions.8–11 Agreement exists that HRQOL is the functional effect of “a medical condition and/or its consequent therapy upon a patient.”8, 11 Therefore, HRQOL is multidimensional and subjective, encompassing occupational and physical function, psychological state, social interaction, and somatic sensation.11 Among patients with prostate cancer, HRQOL can influence activities of daily life, social life, and role function12 and is an important factor in a patient's decision-making process.13 For purposes of this article, we defined health-related quality of life as perceived physical and mental health and function over time.7

The American Physical Therapy Association's (APTA's) Evaluation Database to Guide Effectiveness (EDGE) Task Force was formed within the Section on Research in 2006. The Task Force's goal was to provide physical therapy professionals with a comprehensive list of outcome measures that can be administered to a specific patient population. The psychometric properties and clinical utility within a particular patient population were detailed with the ultimate goal of creating a central location for physical therapy professionals to have access to this valuable information for implementing evidence-based practice.14 The Oncology Section created a Task Force with an initial focus on Breast Cancer Outcomes. The first assessment of breast cancer outcome tools from the Oncology Section Task Force targeted scapula, shoulder, and glenohumeral impairments and shoulder function, the results of which were presented at the APTA Combined Sections Meeting in Chicago 2012 and published in the Rehabilitation Oncology journal.14–16 Succeeding assessments from the Task Force have targeted pain, lymphedema, and fatigue, the results of which have also been subsequently published.17–19 More recently, the Oncology EDGE Task Force expanded its scope to include the assessment of outcome measures in other cancers such as head and neck cancers, prostate cancer, and colorectal cancer.

A variety of HRQOL patient-reported outcome measures have been administered to men with prostate cancer to examine the effects of treatment-related side effects. Several prostate cancer treatments are associated with negative effects on HRQOL.20 Men who received a radical prostatectomy reported greater urinary insentience; external radiotherapy has been associated with bowel side effects, whereas brachytherapy has been related to higher urinary irritative-obstructive symptoms.21–25 Because of the effect prostate cancer treatments have on HRQOL, as well as the variety of patient-reported outcome measures that have been administered, there is a need to identify and decipher the quality of these measures. The primary purpose of this review was to identify and evaluate patient-reported outcome measures for assessing HRQOL in men diagnosed with prostate cancer using the methodology of the EDGE Task Force. The secondary purpose was to make recommendations for use of these patient-reported outcome measures in both the research and clinic settings.

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METHODS

The authors systematically searched the literature for outcome measures that assessed HRQOL in men diagnosed with prostate cancer to evaluate the psychometric properties and clinical utility of these measures. The primary search was conducted from May 2, 2014, in PubMed/MEDLINE and Ovid, with secondary searches occurring through July 2014 in Google Scholar. Search terms used alone and in combination included “cancer,” “neoplasm,” “prostate cancer and prostate neoplasm,” “radiotherapy,” “prostatectomy,” “carcinoma/surgery,” “carcinoma/therapy,” “lymph node excision,” “combined modality therapy,” “lymph node biopsy,” “prostate neoplasms/drug therapy,” “prostate neoplasms/radiotherapy,” “prostate neoplasms/surgery,” “prostate neoplasms,” “hormone therapy,” “prostate neoplasms/androgen deprivation therapy,” along with the following MESH terms: “quality of life” or “health related quality of life.”

The titles, abstracts, and methods section of each article were reviewed to identify outcome measures that were used to assess HRQOL in men diagnosed and treated for prostate cancer. In addition, reference lists from these publications were appraised to identify any other potential publications that should be included in the review. When indicated, full articles were obtained for review. Studies of HRQOL measures/methods that met the following inclusion criteria were reviewed: reporting of psychometric properties, male human subjects, and the study published in the English language. Exclusion criteria included nonclinical measures of HRQOL, studies published without psychometric properties, articles in languages other than English, and articles that examined unidimensional measures of HRQOL such as urinary incontinence or sexual dysfunction. The publication dates were limited to January 1, 1995, and later. A list of 163 publications met these criteria and was divided among 4 reviewers (G.C., M.A., S.H., J.L.) for further analysis. Each outcome measure was reviewed independently and rated by 2 reviewers separately. A total of 34 outcome measures were identified from these publications. After further review of these measures, 14 were excluded because they were not designed to assess the multidimensional aspect of HRQOL such as sexual function or urinary symptoms or were not published in English.

Health-related quality-of-life measures meeting the aforementioned criteria were identified and underwent additional review by the authors S.H., J.L., and M.J.A. Each reviewer was responsible for conducting a primary review of the psychometric properties and clinical utility of their assigned measures. Clinical utility was defined as “the ease and efficiency of use of an assessment, and the relevance and meaningfulness, clinically, of the information that it provides.”26 The Cancer EDGE Task Force Outcome Measure Rating Form was used to guide the primary review for each HRQOL outcome measure.14 Once the reviewers completed their primary reviews, the list was redistributed and a different reviewer performed a secondary review. In cases of disagreement, additional deliberations were performed until a group consensus was reached as whether or not the measure could be recommended for clinical use using the Prostate Cancer EDGE Rating Scale (Table 1).

Fig. 1

Fig. 1

TABLE 1

TABLE 1

TABLE 2

TABLE 2

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RESULTS

After a comprehensive review of the prostate cancer literature, 20 different patient-reported outcome measures of HRQOL were identified for inclusion in this review (Table 2). Of these measures, the ratings of 7 (scored a 4, using the EDGE rating scale) were sufficiently large to warrant recommending their use in clinical and research settings (Table 3). The psychometric properties of the highly rated and recommended outcome measures are presented in Table 4. In general, these 7 measures demonstrate moderate to high reliability (internal consistency and/or test-retest reliability), strong concurrent and/or criterion validity, and responsiveness to change. These factors, along with the clinical utility of the measures, contributed to their high recommendation for clinical use. The PRISMA diagram (Figure 1) demonstrates the literature search and the article selection process.

TABLE 3

TABLE 3

TABLE 4

TABLE 4

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DISCUSSION

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.

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Prostate Cancer–Specific HRQOL Measures

European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire–Prostate 25

The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire–Prostate 25 (EORTC QLQ-PR25) is meant to be used in conjunction with the general cancer EORTC QLQ30 HRQOL questionnaire and is designed to evaluate men with localized or metastatic prostate disease.27, 28 This measure has 25 items examining urinary and bowel symptoms, sexual activity and function, and treatment-related symptoms,27 using a 4-point Likert response scale. The questionnaire exhibits good reliability and validity, although the reported Cronbach αs for bowel function and treatment-related symptoms are only moderate (α = 0.53 and 0.41).27 It was also able to discriminate between patients in curative and palliative stages.27 A minimal clinically important difference of 5 has been reported.29, 30 The instrument is easy to use, available in many languages, and has been used extensively in patients with prostate cancer, in various stages of disease and treatment. It is recommended that it be used with the EORTC QLQ30 for a more comprehensive assessment of HRQOL.

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UCLA–Prostate Cancer Index

The UCLA–Prostate Cancer Index (UCLA-PCI) is a 20-item instrument developed to assess the effect of treatment of early-stage/localized prostate cancer on HRQOL.31 The UCLA-PCI is scored over the following domains: urinary function and bother, sexual function and bother, and bowel function and bother. It has been recommended that the UCLA-PCI be used with a general health questionnaire such as the SF-36 (36 items) and a demographic and medical items form (18 items) to provide a more comprehensive assessment of HRQOL in patients with prostate cancer.31, 32 The UCLA-PCI is widely used, is comprehensive, and has been translated into several languages. Psychometrics are good and have been extensively tested.31–35 The main disadvantage is its length if completed along with demographic/medical items and SF-36. It also does not cover irritative voiding symptoms associated with radiation, which eventually resulted in the development of the Expanded Prostate Cancer Index Composite (EPIC) instrument.36 There is a shorter form of the PCI, with 15 items, and it is recommended for use with SF-12.37 However, this instrument has not been as extensively validated as the original.

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Expanded Prostate Cancer Index Composite

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

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Functional Assessment of Cancer Therapy–Prostate

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.

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General Cancer HRQOL Measures

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

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.

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Functional Assessment of Cancer Therapy–General

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.

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General HRQOL Measures

SF-36, -12, and -8

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.

Five measures, PORPUS (Prostate Cancer Specific Quality of Life), PROSQOLI (Prostate Cancer Specific Quality of Life Instrument), QOLM P14 (Quality of Life Module–Prostate 14), Southwest Oncology Group Prostate Treatment Symptoms Measure, and PCTO-Q (Prostate Cancer Treatment Outcome Questionnaire), were developed for use in individuals with prostate cancer. They were not been recommended for several reasons, including inadequate psychometrics, large response burden, or large scoring burden. For the PROSQOLI and Southwest Oncology Group(SWOG) measures, much of the published data came from the same group that developed the instrument or cites unpublished or ongoing clinical trial data.

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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Keywords:

outcome measure; prostate cancer; quality of life

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