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Oncology EDGE Task Force on Prostate Cancer Outcomes

A Systematic Review of Outcome Measures for Functional Mobility

Davies, Claire C., PT, PhD, CLT-LANA1; Colon, Genevieve, DPT, MBA2; Geyer, Hannah, SPT3; Pfalzer, Lucinda, PT, PhD, FACSM, FAPTA4; Fisher, Mary Insana, PT, PhD, OCS, CLT5

doi: 10.1097/01.REO.0000000000000029
RESEARCH REPORTS
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Background: The medical treatment of prostate cancer results in multiple impairments in body structure and declines functional abilities, resulting in activity limitations and participation restrictions. Measurement of functional mobility is an essential outcome measure in survivorship care.

Purpose: The purpose of this systematic review is to make recommendations of the best measurement tools to assess functional mobility in men treated for prostate cancer based on psychometric properties and clinical utility.

Methods: Multiple electronic databases were searched from February to March 2014. Studies of tools used to assess functional mobility were included if they met the following criteria: reported psychometric properties, were clinically feasible methods, and were published in the English language. Each outcome measure was reviewed independently and rated by 2 reviewers separately. A single Cancer EDGE (Evaluation Database to Guide Effectiveness) Task Force Outcome Measure Rating Form was completed for each category of functional mobility assessment, and a recommendation was made using the 4-point Cancer EDGE Task Force Rating Scale.

Results: Of the original 38 373 articles found, 87 were included in this review.

Conclusion: Seven tests are highly recommended by the Oncology EDGE Task Force, 2-Minute Walk Test and 6-Minute Walk Test, 10-Meter Timed Walk, Timed Up and Go, 5 times sit to stand, based on good clinical utility and psychometric properties.

1Physical Therapist, Rehabilitation Services, Baptist Health Lexington, Lexington, KY

2Physical Therapist, Physical Medicine and Rehabilitation, Covenant Healthcare, Saginaw, MI

3Physical Therapist Student, University of Dayton, Dayton, OH

4Professor Emerita, Physical Therapy Department, University of Michigan–Flint, Flint, MI

5Associate Professor, Department of Physical Therapy, University of Dayton, Dayton, OH

Correspondence: Claire C. Davies, PT, PhD, CLT-LANA, Rehabilitation Services, Baptist Health Lexington, 1800 Nicholasville Rd, Lexington, KY 40503 (claire.davies@bhsi.com).

The authors declare no conflicts of interest.

Prostate cancer is the most common cancer in men in the United States and the second leading cause of cancer death among males.1 The American Cancer Society (ACS) estimates that approximately 181 000 new cases of prostate cancer will be diagnosed in 2016, with mortality at less than 27 000.2 This means approximately 1 in 7 men will be diagnosed with prostate cancer during his lifetime, and most are living many years after the diagnosis. The relative 5-year survival rate in the United States is almost 100% for all stages of prostate cancer, whereas the 10- and 15-year survival rates are 99% and 94%, respectively.3 According to the ACS, more than 2.9 million men in the United States with a diagnosis of prostate cancer are still living as of January 2016.2

As the number of men surviving prostate cancer (PCS) continues to grow, research has demonstrated that many PCS will have significant impairments of body structures and function.3 These impairments often go undetected and/or untreated and consequently may result in frailty.3 Men treated for prostate cancer will experience a decrease in lean muscle mass and strength during the first year of androgen deprivation therapy (ADT), with an estimated 50% of PCS receiving this treatment in the early stages.4 A typical course of ADT may last anywhere from 2 to 3 years. During the first year of ADT, PCS will experience a deficiency in sex hormones, insulin resistance, increased central/visceral adiposity, decreased bone density, decreased lean muscle mass, and whole body muscle strength.4 Adverse changes in muscle composition may exacerbate normal sarcopenia, further reducing muscular strength and endurance as well as functional mobility and independence.5 A study of older PCS (mean age 69 years) found that these men are at a greater risk for other comorbid conditions and physical limitations (eg, cardiovascular disease, diabetes, osteoporosis, skeletal fractures, impaired balance, and falls) that may dramatically affect their muscle performance and physical function.6

Evidence of the effect of ADT and cancer treatments on PCS is consistently strong in terms of a detrimental effect on functional abilities. In a recent study of PCS posttreatment, 24% had impairments in activities of daily living (ADL), 42% had impairment in instrumental activities of daily living (IADL), 56% had abnormal Short Physical Performance Battery (SPPB) findings, and 22% reported falls within the previous 3 months.4 Within the SPPB, deficits occurred within all subcomponents (balance, walking, and chair stands). Using a univariate analysis, age, deficits in ADL and IADL, and abnormal cognitive and functional screen findings were associated with an increased risk of decreased physical performance for PCS.6 When compared with age-matched healthy controls, survivors had a slower walking speed, poorer physical performance, and lower levels of patient-reported physical function. Decreased gait speed is associated with mobility limitations, disability, and increased mortality. Deficits in ADL, the use of an assistive device, and abnormal functional screening findings were associated with an increased risk of falling.6 Falls may lead to more serious injuries such as an increased risk of fractures and hospitalizations, thereby decreasing the quality of life and level of independence for survivors. In summary, the multitude of physiological changes resulting from ADT of prostate cancer profoundly impacts the functional mobility of these men. It is therefore essential to measure functional mobility in order to identify deficits, risks for further injury such as falls, and design and assess the effectiveness of appropriate treatment regimens.

In 1991, the Task Force on Standards for Measurement in Physical Therapy of APTA established the criteria for valid, reliable, objective, and standardized tests and measures to assist clinicians in providing the highest quality of care.7 The assessment of appropriate outcome measures needs to consider the following elements: (1) which domain within the International Classification of Functioning, Disability, and Health (ICF) that the test measures; (2) the purpose of the measure relevant to obtaining discriminative, predictive, or evaluative information; (3) whether the measure is disease specific or more generic and whether it is a self-report versus performance-based measure; (4) the patient's ability and goals, and the clinic's requirements; (5) the psychometric properties, particularly reliability, validity, diagnostic accuracy, minimal detectable change (MDC), and minimal clinical important difference (MCID); and (6) the feasibility, including the time, equipment, cost, space, and training required to administer and score the test results, overall burden on the patient to complete the test, and consideration of culture and language barriers.8 The use of standardized outcome measures is an essential component of evidence-based practice and enhances communication with patients and payers.9 The leading barriers to a standardization of physical therapy outcome measures are primarily the lack of knowledge of the psychometric strength of measures as well as the clinical utility of these measures including the length of time and level of difficulty for patients to complete the test as well as the time necessary for clinicians to administer and interpret the results of the tests.10 The EDGE (Evaluation Database to Guide Effectiveness) Task Force was developed to address these barriers in the physical therapy profession.

In 2010, the APTA's Oncology Section created an EDGE Task Force to develop recommendations for outcome measures used when assessing the status of cancer survivors.11 The reliability, validity, MDC, and/or MCID are important psychometric properties that need to be evaluated to justify clinical use of outcome measures.8 In addition, tools used to track and measure patient outcomes should be validated in the population in which they are used to be most beneficial. Finally, these tools need to be evaluated in light of clinical utility, including the availability of resources, cost, ease of use, and availability of normative data. To date, Oncology EDGE Task Forces have reviewed quality-of-life measures and measures of strength and muscular endurance for the prostate cancer population.12,13 These reviews are in addition to 13 reviews completed for the breast cancer population,14–26 4 reviews completed for the head and neck cancer population,27–30 and 1 review for the colorectal cancer population.31 The purpose of this systematic review is to make recommendations of the best methods to evaluate functional mobility in PCS based on psychometric properties and clinical utility.

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METHODS

Search Strategy

The authors systematically assessed the literature for outcome measures that either directly measured or used patient self-report to evaluate functional mobility with the express purpose of evaluating the psychometric properties and clinical utility of these measures for patients with prostate cancer. The primary literature search took place from February to March 2014 using electronic databases such as Google Scholar, Ovid, PubMed/MEDLINE, CINAHL, Sports Discus, Web of Science, Cochrane Review, and PEDro. Search terms focused on prostate cancer and functional mobility (refer to Appendix 1 for a full list of search terms).

Studies of tests of functional mobility had to report psychometric properties, present clinically feasible methods, have adults (preferably male) as participants, and be published in the English language to be included in this review. Articles were taken into consideration if published after 1995 through March 2014. The authors chose to search from 1995 in order to include any seminal research pertinent to the measures investigated. The prostate cancer population took first priority within the search; however, if no studies included this population, patients with other cancers, geriatric patients, other medically complex patients, and the general population were considered for review. With the use of such inclusion criteria, we were unable to provide evidence on all tests searched and therefore the list of such tests exceeds the number included in the final review.

After completion of the literature search, the relevant articles were classified into 3 functional categories consisting of the following: walk tests; ADL functional tests (physical and self-report); and self-reported community participation. Each functional category included a series of tests and assessments. Refer to Appendix 2 for measures within each category.

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Data Extraction and Analysis

Each outcome measure was appraised by 2 reviewers independently using the Cancer EDGE Task Force Outcome Measure Rating Form.11 Pertinent information regarding population studied, psychometric information related to the measure of interest, and evidence of clinical utility were gathered. Assessment of psychometric properties included reliability, where excellent reliability is more than 0.90, good reliability is 0.76 to 0.89, moderate reliability is 0.50 to 0.75, and poor reliability is less than 0.50.32 Concurrent, discriminative, criterion-related, and construct validity values are reported when available, as well as measures assessing responsiveness to change such as MDC and MCID; the standardized response mean was also reported if that was the only measure of responsiveness available.

Outcome measures were then rated 1 to 4 (lowest to highest recommendation) on the Cancer EDGE Rating Scale, taking into consideration both psychometric qualities and clinical utility (see Table 1). If the 2 reviewers agreed on the rating of the outcome measure, the rating stood. If an outcome measure rating was found to be in disagreement between the 2 independent reviewers, the disagreement was resolved by discussion with all 5 reviewers until agreement was reached. Finally, all articles reviewed for an outcome measure were included in a reference section of the EDGE form for each appropriate measure.

TABLE 1

TABLE 1

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RESULTS

The initial literature search of electronic databases and bibliographic review for functional mobility assessments of those treated for prostate cancer resulted in 38 373 articles including duplicates. After title and abstract review, and removal of duplicates, 248 articles were retrieved and assessed for eligibility. A total of 152 articles met inclusion criteria and were included in the final review. Figure 1 delineates the flow of the literature search.

Fig. 1

Fig. 1

Each functional mobility category included multiple tests. For 10 walk tests, 100 articles were reviewed. For 5 ADL functional tests, 22 articles were reviewed. For the self-reported community participation, 30 articles were reviewed for the 7 measures assessed. Some research studies included psychometric analysis of multiple measurement tools such that the number of articles included within each category is not mutually exclusive.

Overall, 7 measures are highly recommended (rated 4) by the Oncology EDGE Task Force. All highly recommended measures are in the walk test category: 2-Minute Walk Test (2-MWT) and 6-Minute Walk Test (6-MWT), 10-Meter Timed Walk (10-MTW), Timed Up and Go (TUG), 5 times sit to stand (5xSTS), SPPB, and the Physical Performance Battery for Patients with Cancer (PPB). Three ADL tests are recommended (rated 3) by the Task Force, and include the Assessment of Life Habits (LIFE-H), the Functional Independence Measure (FIM), and the Activity Measure for Post-Acute Care (AM-PAC). Table 2 provides summary information regarding recommended measurement tools.

TABLE 2

TABLE 2

Table 3 lists outcome measures not recommended by the EDGE Task Force, with a description of weaknesses of the measures. The Oncology EDGE Task Force is unable to recommend (rated 2B) the 12-Minute Walk Test (12-MWT) or the Timed 25-Foot Walk in the walk test category, or the Barthel Index and the Canadian Occupational Performance Measure (COPM) in the ADL Functional Mobility category. No measures in the self-reported community participation achieved a rating of 3 or 4. The Impact on Participation and Autonomy Questionnaire (IPAQ), the Life Satisfaction Questionnaire (LISAT-9), the Modified Rankin Scale, and the Participation Objective, Participation Subjective (POPS) are rated 2B, unable to recommend, and the Participation Survey of Mobility Limited People (PARTS-M), Functional Status Examination (FSE), the High-Level Mobility Assessment Tool (HiMAT), and the Reintegration to Normal Living/Life Index are all not recommended (rated 1) by the Task Force.

TABLE 3

TABLE 3

Table 4 provides details on clinical utility of recommended measures. A summary of psychometric properties for the recommended measures are found in Table 5 (reliability and responsiveness data) and Table 6 (validity data).

TABLE 4

TABLE 4

TABLE 5

TABLE 5

TABLE 6

TABLE 6

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DISCUSSION

The purpose of this systematic review is to make recommendations of the best methods to evaluate functional mobility in PCS based on psychometric properties and clinical utility. Men treated for prostate cancer with ADT are known to have reduced lower body strength by 22% and decreased bone density compared with healthy controls5,66–68; combined with increased age, this combination sets up an increased risk for falling with functional activities such as rising from a chair, dynamic balance activities such as reaching, and slowing gait speed with ambulation.68 It is important to assess walking, balance, and functional ability in the home and community environments during the initial examination to determine the presence of physical impairments, functional deficits and activity limitations, and participation restrictions, to identify the effect of cancer treatment on the individual's overall function, including fall risk.

Within the ICF, functional mobility is included in the mobility domain and intersects with ADL and participation within environment and life situation contexts. This review includes multiple measures of walking, ADL, and self-reported community function. The 7 highly recommended (rating of 4) and 3 recommended (rating of 3) measures are discussed; the remaining measures reviewed that lack either psychometric support or clinical utility are not recommended for use by the EDGE Task Force. Included highly recommended measures are as follows: 2-MWT and 6-MWT, 10-MTW, TUG, 5xSTS, SPPB, and PPB. Recommended measures include the LIFE-H, the FIM, and the AM-PAC. Most of the recommended measures (n = 7) are from the walk test category, whereas 3 are from the ADL category.

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Walk Tests

The ability to walk safely and competently is essential for an individual to move around the environment. The 2-MWT and the 6-MWT involve the individual walking as far as they can in 2 or 6 minutes, respectively. A participant may rest at any time and use a walking aid as needed. These tests demonstrated good-excellent reliability in older adults, neurological populations, and amputees (interclass correlation coefficient [ICC] = 0.83-0.96).33,34,36 Reliability of the 6-MWT was examined in a mixed cancer cohort and is excellent with an ICC of 0.93.38 Discriminant validity was established with community-dwelling adults and those in long-term care.33 The 2-MWT has moderate to high concurrent validity with the TUG, as well as other walk tests such as the 6-MWT, the 12-MWT, and the 10-MTW.33,36,59,62 There is moderate concurrent validity of the 6-MWT with the SPPB and the 5xSTS62; it also demonstrates moderate concurrent validity with the physical function subscale (r = 0.50) of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36),61 and the perceived Physical Function (r = 0.55) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30).38 Both the 2-MWT and the 6-MWT are easy to administer clinically and their common clinical use and available normative data33,60,69 allow for rapid interpretation by the clinician. The established MDC95 for the 6-MWT is 5.2%,37 and the MCID of 140 ft is reported for PCS.39 The 2-MWT may have a slight edge in terms of clinical utility, as it takes less time to administer, may be more feasible for those with significant levels of fatigue or muscle weakness, or a gait dysfunction that results in greater energy consumption.70 Both the 2-MWT71 and the 6-MWT38,39,72 have been used to assess outcomes in research studies involving PCS.

The 10-MTW is also highly recommended for use by the Oncology EDGE Task Force. This test measures the time it takes to walk the distance of 10 m. Gait speed is calculated as the time it took to complete the test is divided by the distance. The 10-Meter Walk Test has been used in studies among men with prostate cancer and demonstrates excellent reliability (ICC = 0.90-0.97).73–82 Furthermore, this test was validated with dependence in self-care, domestic life, and mobility, with IADL, the Barthel Index, the 6-MWT, and the TUG.79,83,84 The responsiveness of the 10-MTW has been investigated and the MDC is 0.013 to 0.25 m/s.74,75,83,85 The ease of administration of this test and available normative data78,81,86,87 make it a good test to use clinically.

Another highly recommended test is the TUG. This test involves an individual rising from sitting in a standard armchair, walking for 3 m, then turning and walking back to the chair and sitting down.88 The time to complete this test is recorded. The TUG has moderate to excellent reliability (ICC = 0.85-0.96).34,37,43 Concurrent validity was established with the 2-MWT and the FIM.59 In the cancer population, the time on the TUG predicts falls within 3 to 12 months of diagnosis.43 Normative data are available for the TUG for community-dwelling elders as well as for PCS.39,89–92 In addition to psychometric data related to PCS, the TUG has been used as an outcome measure in research with men treated for prostate cancer.39,93

The 5xSTS is also highly recommended. This test involves rising from a standard chair 5 times as fast as possible, with arms folded across the chest, and is focused on transitional movements and lower extremity strength.94 The time to complete the test is recorded in seconds. This test is easy to administer in the clinic and is reliable in older female adults (ICC = 0.95).44 The 5xSTS was validated with the 6-MWT62 and the TUG.44 The MDC in older female adults is 2.5 seconds.44 In addition, this test was used in research on the prostate cancer population.72,95,96 This test incorporates assessment of both transitional movement and a functional measure of lower extremity strength, making this a useful clinical tool.

Two functional performance batteries, SPPB and PPB, are highly recommended by the EDGE Task Force. The SPPB is a collection of physical tests that determine function in ADL. The SPPB is easy to administer and involves walking at a normal pace, a balance task, and incorporates the 5xSTS.97 The design of the test makes it relatively easy to administer in a clinical setting and seeks to quantify physical performance on a number of simple skills required for functional mobility.97 Reliability is good (ICC = 0.83-0.89),98–101 and it is validated with self-reported mobility and ADL with associated disability.97 The MDC in the elderly population is 1.42 to 2.9 points42,102 and in a population of older adults after hip fracture, the MDC is 3.42 points.103 This test was used in research with individuals with advanced cancer, including prostate cancer.104

The PPB was specifically designed for the oncology population and has been used in research with men treated for prostate cancer.105 The PPB includes 9 tests, and although it may take up to 40 minutes to complete, the test demonstrated moderate to excellent reliability (ICC = 0.69-0.99) in a general cancer population.45 Concurrent validity of the separate subtests (walk, sit to stand, 6-MWT) was established with the TUG43 and with the Functional Status Index.45 The PPB was designed for use with those with cancer and includes a comprehensive evaluation of physical performance, making this a promising test to incorporate into clinical measurement.

The remaining walk tests include the 12-MWT and the Timed 25-Foot Walk, which are both rated 2B, unable to recommend, by the EDGE Task Force. Both of these tests have lower psychometric strength or lack adequate testing of psychometric qualities. The 12-MWT may be difficult to administer in an individual with a lower level of function secondary to the duration of the test, and the Timed 25-Foot Walk has only been tested with a neurological population, making generalization to men treated for prostate cancer difficult.

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ADL Functional Tests

Three ADL functional tests are given a rating of 3, recommended, the highest rating given by the EDGE Task Force in this category. They are the LIFE-H, the FIM, and the AM-PAC. The LIFE-H has both a long form and a short form, covering 12 domains, with the number of items being 240 and 69, respectively.46,48–51 The domains include personal care, interpersonal relationships, nutrition, community life, recreation, and mobility, with the intent to assess the perception of one's ability to participate socially. The scoring is complex and the time to administer the test (1 hour for the short form and 2 hours for the long form) may impact its clinical utility. However, sound psychometric properties and the comprehensive nature of the test warrant the investment of time. The validity of the LIFE- H has not been reported in a cancer population.

The FIM contains 18 items comprising 5 cognitive and 13 motor tasks. The FIM is used to assess quality of life in persons with a disability and the need for assistance to complete activities within the individual's environment.106 The FIM has good psychometric properties54,55,63,107; however, its clinical utility may be restrictive as the FIM has a cost associated with use, takes 30 to 40 minutes to administer, and is scored via consensus with other health care providers. Also, therapists need to be trained to use the tool. Despite these barriers to implementation, the EDGE Task Force recommends this tool because of the comprehensive nature of the assessment, which provides the clinician with a clear picture of the effect of function on quality of life and daily activity. Use of the FIM has not been reported in the prostate cancer population.

The AM-PAC was developed to assess functional status of all individuals across the continuum of care.65 Based on ICF domains, the AM-PAC is a self-report 41-item comprehensive scale to test physical and movement activity (10 items), personal care and instrumental activity (16 items), and applied cognitive activity (15 items). The test-retest reliability is excellent (ICC = 0.91-0.97),56,65,108 and validation with proxy scoring is moderate-good (ICC = 0.68-0.90).56 Furthermore, shortened computer-assisted testing versions are available that demonstrate excellent concurrent validity with the full version (r > 0.90).108–110 Although a broad population was recruited to examine the psychometric properties of this tool, this measure has not been specifically reported in the cancer population.

The Task Force is unable to recommend the remaining ADL measures including the Barthel Index and the COPM because of limited psychometric support and lack of evidence of use in a cancer population.

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Self-reported Community Participation Measures

No measures in this category are recommended because of poor psychometric properties, poor clinical utility, and lack of evidence of use in a cancer population. The IPAQ, the LISAT-9 Modified Rankin Scale, and the POPS are all rated 2B. The PARTS-M, HiMAT, FSE, and Reintegration to Normal Living/Life Index are not recommended by the Task Force.

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LIMITATIONS AND FUTURE RESEARCH

Evidence-based practice requires that the best evidence available is used in clinical judgment, along with clinician expertise and patient values. The EDGE Task Force investigating measures of functional mobility for use with PCS acknowledges limitations to this study. The literature search was completed in March 2014 and therefore does not include any studies published thereafter, which might color the lens through which the analysis of findings is viewed. It is possible that newer studies would provide additional psychometric data to evaluate existing measures or that new measures may have been developed. Limiting the search to English publications could also limit the access to evidence supporting particular measures. The Task Force recommendations are made with the best available evidence at the time, but in using these measures, the reader is encouraged to continue to use best judgment in applying these recommendations to the individual patient.

Clearly, additional research is needed in validating all of these measures in the prostate cancer population. Studies examining reliability and responsiveness to change of these measures in men treated for prostate cancer are a significant gap in the evidence database. More studies using these measures as outcomes need to be developed. Perhaps, most importantly, better measures of assessing functional mobility within the context of community participation need to be developed.

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CONCLUSION

In patients with prostate cancer, with or without ADT, the assessment of functional mobility is important to assess impairment, functional deficits, activity limitations, and participation restrictions. Multiple assessment tools exist to assess walking and ADL; however, limited research in self-reported community participation tools render them inadequate at this time. Seven tests are highly recommended by the Oncology EDGE Task Force: 2-MWT, 6-MWT, 10-MTW, TUG, 5xSTS, SPPB, and PPB, based on good clinical utility and psychometric properties. Three tests are recommended but lack use in the cancer population: LIFE-H, FIM, and AM-PAC. Further research is needed to establish psychometric properties of other current measures, including validation among PCS, or to develop new assessment tools in the prostate cancer population.

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Table

Table

APPENDIX 2

APPENDIX 2

Keywords:

functional mobility; outcome measures; prostate neoplasms; psychometrics; Short Performance Physical Battery and Physical Performance Battery for Patients with Cancer

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