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Oncology Section EDGE Task Force on Cancer: A Systematic Review of Clinical Measures for Pain

Harrington, Shana E., PT, PhD1; Gilchrist, Laura, PT, PhD2; Lee, Jeannette, PT, PhD3; Westlake, Frances L., PT, DPT4; Baker, Alicia, PT, DPT5

doi: 10.1097/01.REO.0000000000000097
META ANALYSIS & SYSTEMATIC REVIEWS

Background: Pain is one of the most common complaints in individuals with cancer and can occur at any point during the course of cancer treatment.

Purpose: To identify outcome measures for assessing pain and to evaluate their psychometric properties and relevance to adults with a diagnosis of cancer.

Methods: Three electronic databases (CINAHL, MEDLINE, and PsycINFO) were reviewed using specific search terms to locate articles that identify outcome measures assessing pain in adults with a diagnosis of cancer. From the 1164 articles identified, 494 articles were reviewed and 22 outcome measures were selected for analysis. Each outcome measure was independently reviewed and rated by 2 reviewers using the updated Cancer EDGE Task Force Outcome Measure Rating Form. Any discrepancies between reviewers were discussed, and an overall recommendation for each measure was made using the 4-point Cancer EDGE Task Force Rating Scale.

Results: On the basis of the psychometric properties, clinical utility, and relevance to adults with a diagnosis of cancer, the following 3 measures are highly recommended: McGill Pain Questionnaire–Short Form, Numeric Rating Scale, and Visual Analog Scale. Four measures are recommended: Brief Pain Inventory, Brief Pain Inventory–Short Form, McGill Pain Questionnaire, and Pain Disability Index. Eleven measures are recommended as reasonable to use, and 3 are not recommended.

Conclusions: Seven of the 22 pain measures demonstrated satisfactory psychometric properties and clinical utility and are thereby recommended for clinical and research use in adults with a diagnosis of cancer.

1Board-Certified Sports Clinical Specialist, and Clinical Associate Professor, Physical Therapy Program, University of South Carolina, Columbia, SC

2Professor, Doctor of Physical Therapy Program, St Catherine University, Minneapolis, MN

3Associate Professor, UCSF/SFSU Graduate Program in Physical Therapy, San Francisco, CA

4Board-Certified Neurologic Clinical Specialist, and Staff Physical Therapist, Oncology Rehab, Centennial, CO

5Staff Physical Therapist, Good Samaritan North Rehabilitation & Sports Medicine Center, Dayton, OH

Correspondence: Shana E. Harrington, PT, PhD, Physical Therapy Program, University of South Carolina, Columbia, SC 29208 (Heel1998@aol.com).

The authors above have no reported conflicts of interest.

The International Association for the Study of Pain defines pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.”1 Pain, in addition to fatigue, is one of the most common complaints in those with a diagnosis of cancer.2 Adults with a diagnosis of cancer often report a high prevalence of pain that is related to a lower quality of life and function.3 Pain from cancer is often multifactorial and may be due to surgery, radiation, or chemotherapy or may be preexisting.4 The following prevalence of pain has been reported in the cancer literature: breast, 40%-89%; genitourinary, 58%-90%; head and neck, 67%-91%; pancreatic, 72%-85%; prostate, 56%-94%; and uterine, 30%-90%.4 Estimates of the prevalence of cancer-related pain have varied widely, mainly because of a lack of standardization in definitions of pain, the measures used to assess pain, and the heterogeneity of nociceptive and neuropathic pain conditions.4 It is important to understand that pain experienced by adults with a diagnosis of cancer is complex and could be classified as neuropathic, nociceptive, and/or central sensitization pain.2

van den Beuken and colleagues5 completed a systematic review on the prevalence of cancer-related pain searching the literature published between September 2005 and January 2014 using the PubMed, MEDLINE, EMBASE, CINAHL, and Cochrane databases. Articles in English or Dutch that reported on the prevalence of cancer pain in an adult population were included.5 The review found that patients reported pain 39% after curative treatment of cancer, 55% during anticancer treatment, and 66% in advanced, metastatic, or terminal cancer.5 The authors concluded that pain continues to be a prevalent symptom not only during cancer treatment but also even after treatment has commenced and there needs to be increased attention on assessment and management of pain in this population.5 In addition, they recommend developing and implementing interventions to optimally manage pain in adults with a diagnosis of cancer.2 , 5

Although many measures exist to assess pain, few studies have appraised the psychometric properties and clinical utility of these outcome measures. There are a few reports on assessment of cancer-related pain, although they are not systematic reviews.6 , 7 The authors are aware of only 1 systematic review that examined pain outcomes in women with breast cancer.8 To the authors' knowledge, no previously published work has evaluated pain across a variety of adult cancer populations or made recommendations on which outcomes have sound psychometric properties and good clinical utility. Therefore, the purpose of this review was to critically appraise pain outcome measures to provide recommendations on measures with sound psychometrics that are clinically useful to evaluate pain in adults with a diagnosis of cancer.

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METHODS

To generate a list of candidate outcome measures, the authors, with the help of a Creighton University librarian, systematically searched the literature for outcome measures that assessed pain and proceeded to evaluate the psychometric properties and clinical usefulness of those measures. The primary search was conducted in CINAHL, MEDLINE, and PsycINFO. Terms specific to the search strategies are listed in Table 1. Research articles were included for consideration if the text was available in English, pain measures were used in individuals with cancer, published from 2005 to 2016, used clinically feasible methods, and had reported psychometric properties. The initial search of the literature returned 1164 articles, 670 of these did not meet the inclusion criteria, leaving 494 articles to be included in the primary review. After review of these articles, 35 pain outcome measures were identified. The authors had several discussions and decided for purposes of this review to exclude outcomes that were specific to the pediatric population and those outcomes that were considered a psychosocial tool such as the Chronic Pain Self-Efficacy Scale, Pain Catastrophizing Scale, and the Fear of Pain Questionnaire. This led to a final of 22 outcome measures identified and selected for review (Figure 1).

Fig. 1

Fig. 1

TABLE 1

TABLE 1

Each outcome measure was independently reviewed by 2 members of the research team using the Cancer EDGE Task Force Outcome Measure Rating Form (Table 2). This form details information about psychometric properties including reliability, validity, minimal detectable change (MDC), and minimal clinically important differences (MCIDs) as available. Clinical utility was also addressed, which included availability of the measure, length of the questionnaire, cost, time required to complete, scoring, and interpretation (Table 3). As part of the assessment, each reviewer ranked the outcome measure using the Cancer EDGE Rating Scale described in Table 2. Discrepancies between reviewers were discussed until a consensus was reached for all ratings and recommendations.

TABLE 2

TABLE 2

TABLE 3

TABLE 3

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RESULTS

A comprehensive review of the literature yielded 22 outcome measures that assessed pain in adults with a diagnosis of cancer. Of these, 3 measures received the highest rating (4 = highly recommend) and 4 received the second highest rating (3 = recommend). Eleven measures are recommended as reasonable to use, but it is important to note that there are limited studies using these measures in the cancer population to support a higher recommendation. Three of the outcomes reviewed are not recommended because they have poor psychometric properties and/or poor clinical utility. The ratings of the 22 assessed outcome measures are presented in Table 4.

TABLE 4

TABLE 4

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DISCUSSION

The purposes of this review were to systematically identify and analyze outcome measures for assessing pain in the adult cancer population and to recommend outcome measures with adequate psychometric properties and clinical usefulness. Two of the recommended measures are unidimensional in nature and typically investigate pain intensity or severity, whereas 5 are considered multidimensional and investigate additional characteristics such as pain quality and interference with daily activity. Three measures were highly recommended, and 4 additional measures were recommended. The clinical utility (Table 3) and psychometric properties (Table 4) of the highly recommended and recommended measures are discussed in the following text.

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McGill Pain Questionnaire–Short Form

EDGE Rating: 4 (Highly Recommend). The purpose of the McGill Pain Questionnaire–Short Form (MPQ-SF) is to measure the diverse qualities of the subjective pain experience using an abbreviated, less time-consuming version of the original McGill Pain Questionnaire (MPQ).9 The MPQ-SF is a multidimensional tool that takes approximately 25 minutes to complete, contains 15 words from the original MPQ (11 sensory and 4 affective descriptors) rated on a 0 to 3 scale, 1 item for present pain intensity (PPI) (0-5 scale), and 1 visual analogue scale (VAS).9 , 10 The MPQ-SF is a paper-and-pencil/pen self-administered questionnaire available at no cost.9 To score the MPQ-SF, the 15 pain descriptors are rated as none, mild, moderate, or severe, corresponding to 0, 1, 2, or 3 points, respectively.9 , 10 The total of these descriptors is summed and scored ranging from 0 to 45.9 , 10 Affective and sensory subscale scores are obtained by summing the scores from the sensory and affective pain descriptors, respectively. Scores on the PPI range from 0 to 5, and the VAS scores range from 0 to 10.9–11

The MPQ-SF has been used and validated in examining pain in a wide variety of health conditions including chronic pain,12 postoperative pain,13 rheumatoid arthritis and fibromyalgia,14 and cancer.15 , 16 Reliability and validity are good in a variety of pain conditions including cancer. The 15 items on the MPQ-SF were found to be highly internally consistent (Cronbach α = 0.91) in patients with lung cancer.16 Reliability using the Cronbach α for total, sensory, and affective items ranged from 0.85 to 0.94 for Asian American adults with a diagnosis of cancer.17 Concurrent validity with the long-form MPQ was found to be r = 0.77-0.88 in adults with a diagnosis of cancer pain.15 In patients with chronic cancer pain, all domains of the MPQ-SF correlate very highly with the long-form MPQ, demonstrating convergent construct validity. When looking at changes over 3 to 4 weeks, the correlation between the short-form and long-form MPQ in the sensory, affective, total, and PPI scores ranged from 0.35 to 0.76.15

The MPQ-SF has been found to be sensitive to change in 3 groups of patients administered different types of analgesia—epidural anesthetic for labor pain, transcutaneous nerve stimulation for musculoskeletal pain, and analgesic drugs for postsurgical pain.11 There is no described MDC, but an MCID has been reported for a mean improvement in total scores of more than 5 on the 0 to 45 score for the 15 pain descriptors.9 , 18 The MPQ-SF has been administered in studies of a variety of cancer diagnoses including breast, colorectal, lymphoma, prostate, lung, gastrointestinal, genitourinary, gynecological, head and neck, kidney, and melanoma.15 , 19

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Numeric Rating Scale

EDGE Rating: 4 (Highly Recommend). The Numeric Rating Scale (NRS) is a unidimensional measure of pain intensity, commonly from 0 to 10 or 1 to 10. Usually, only the 2 extreme categories are labeled, for example, “no pain at all” and “worst imaginable pain,” and the respondent selects the number that best reflects the intensity of his or her pain.20 Hawker and colleagues10 note that the 11-item NRS (0-10) is the most commonly used. The NRS can be administered verbally or visually; if the latter is used, the most common format is a horizontal bar or line with a segmented, numbered scale and anchored terms describing the pain intensity extremes.21 Subjects verbally report their pain rating. It takes less than 1 minute to complete, and the number that the respondent indicates on the scale to rate his or her pain intensity is recorded where the higher the score, the greater the pain intensity.22

Psychometrics for the NRS have been reported in a number of patient conditions, including a variety of cancers. In adults with a diagnosis of cancer, Jensen23 reported good stability for the NRS rating of worst pain (r = 0.93) and average pain (r = 0.78) but not for current pain (r = 0.59) during a 2-day period. In another study, the coefficient α for the NRS used for measuring present, average, worst, and least pain in a population with cancer was 0.81.24 Reproducibility was 0.86 (Cohen's K) when measuring pain exacerbations in a population of patients with advanced cancer with pain.25 Convergent validity of the NRS compared with the VAS is strong (r = 0.847, P = .001) in a population with cancer.26 The NRS has demonstrated good criterion validity through significant correlations with analgesic medication and other specific cancer-related symptoms.23 A reported 2-point change represents a clinically meaningful difference.27 , 28 Responses on the NRS were able to predict decreases in functioning in patients with various cancer diagnoses.29 For cancer pain, NRS scores can be categorized as mild (1-3), moderate (4-6), or severe (7-10).24 , 30 Scores that are greater than 5 may have an adverse effect on health-related quality of life.31

The NRS has been used extensively in both clinical and research settings, with numerous studies involving patients with the following cancer diagnoses: chronic cancer pain, breast cancer, neuropathic cancer pain, head and neck, palliative care, liver, pancreatic, gastric, colorectal, hematologic, lung, genitourinary, and multiple myeloma.23–26 , 29 , 30 The NRS has the disadvantages of many unidimensional measures in that it measures only one aspect of the pain experience (intensity) where the overall pain experience in adults with a diagnosis of cancer may require a more multidimensional measurement tool.32

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Visual Analog Scale

EDGE Rating: 4 (Highly Recommend). The VAS is a unidimensional tool that measures intensity of pain. The VAS comprises a 10-cm long horizontal line with anchors on each end, for example, “no pain” anchoring one end and “pain as bad as it can be” at the other. The respondent places a mark on the line that represents his or her pain intensity, and the distance measured from the “no pain” end to the line is that person's VAS pain score.23

The VAS has been validated in the acute,33 chronic,34 and cancer populations.20 This measure has shown acceptable test-retest reliability of 0.80,16 , 23 concurrent validity with other pain scales in a cancer population of 0.70,23 , 35 and an established MCID of 9 to 11 mm in the breast cancer population.36 The VAS has shown sensitivity to changes in cancer pain associated with treatment or time.23 The VAS has been used extensively in various cancer populations including chronic cancer pain, breast, palliative care, head and neck, prostate, colorectal, and lung.

Despite the strong reported psychometric properties for the VAS, there is evidence that this tool may be more difficult than other pain measures for patients to understand and complete.23 One study found that 16% of 101 palliative care patients were unable to complete the VAS even with assistance from a nurse, and this number increased to 84% as the disease progressed.37 Research has shown that administering the VAS to elderly patients is associated with a higher failure of completion rates than other unidimensional tools such as the NRS.38 , 39 In addition, many cancer survivors are prescribed opioids for pain from cancer and/or treatments; difficulty understanding the VAS has been found when patients are taking this type of medication.40

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Brief Pain Inventory

EDGE Rating: 3 (Recommend). The Brief Pain Inventory (BPI) is a multidimensional tool that was developed specifically for use in individuals with cancer41 and contains 32 items comprising questions on pain intensity and pain-related interference with function.41–43 Individuals rate their worst, least, average, and current pain intensity (including the last 24 hours), as well as the degree to which pain interferes with 7 domains of function: (1) general activity, (2) mood, (3) walking ability, (4) normal work, (5) relations with other persons, (6) sleep, and (7) enjoyment of life using a scale from 0 (no pain) to 10 (pain as bad as you can imagine).44 The BPI takes approximately 10 to 15 minutes to complete and can be given in a paper-and-pencil format or orally.41 It is important to note that there is a cost associated with its use.45

The BPI has good reported psychometrics in persons with cancer. Short-term test-retest reliability in a mixed cancer population found correlations that ranged from 0.59 to 0.93.46 The Cronbach α ranged from 0.81 to 0.89 in a mixed cancer population with metastatic pain that included breast cancer.47 Construct validity found 3 factors—pain intensity, activity interference, and affective interference—that were invariant across age, disease, and ethnicity.47 , 48 MCID has not been reported for the BPI. The BPI has been reported in the literature for the following cancer diagnoses: breast, gastrointestinal, gynecologic, hematologic, lung, melanoma, metastatic (bone), prostate, renal cell, and solid tumors. It is important to note that there is a cost associated with its use.45

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Brief Pain Inventory–Short Form

EDGE Rating: 3 (Recommend). The Brief Pain Inventory–Short Form (BPI-SF) was developed from the BPI to decrease the amount of time required to complete and for “brevity sake and for the patient's ease of use.” The BPI-SF is recommended over the BPI by the developer.45 The short form retains the front and back body diagrams, the 4 pain severity items (worst, least, average, and now), and 7 pain interference items (general, activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) rated on a 0 to 10 scale; there is also 1 question about the percentage of pain relief by analgesics.49 Besides being shorter, another main difference in the short form is that it uses a 24-hour recall as opposed to a 1-week recall period found on the long form.49 , 50

Reported psychometric properties have been primarily for those with breast cancer. The Cronbach α was found to be 0.89 in 36 women with a diagnosis of stage I-IIIA breast cancer.51 Construct validity has been reported to be high for the pain interference (0.71-0.94) and pain severity (0.70-0.91) constructs of the BPI-SF.52 The minimal important difference has been reported as 1.2 points for pain severity, 1.6 points for activity-related pain interference, and 1.5 points for mood-related pain interference.50

The BPI-SF has been reported in the literature for the following cancer diagnoses: breast, gastrointestinal, lung, prostate, solid tumors, bone metastases, and multiple myeloma.53 It is important to note that there is a cost associated with its use.45

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McGill Pain Questionnaire

EDGE Rating: 3 (Recommend). The MPQ is a multidimensional pain measure that examines the qualitative and affective components of pain.23 The MPQ examines 4 different aspects of pain: (1) sensory, which includes pain location, intensity, quality, and pattern; (2) affective, which includes fear, depression, and anxiety related to pain; (3) evaluative, which includes the overall pain appraisal; and (4) miscellaneous, which includes aggravating and alleviating actions.54 The MPQ contains 3 parts, 78 pain descriptors (known as the number of words chosen), a pain rating index, and a 0- to 5-point pain intensity scale.11 Different times to complete have been reported, from approximately 10-15 minutes10 to 20 minutes55 or 30 minutes.56 For inpatients with a diagnosis of cancer, a time to complete of approximately 24 minutes has been reported with a range of 12 to 45 minutes.57 The computerized version of the MPQ has a reported time to complete of 16 ± 6.7 minutes.58

The MPQ has demonstrated good test-retest reliability of 0.70,59 construct validity (sensory, affective and cognitive),35 , 57 , 59 , 60 concurrent validity (r = 0.31-0.40),58 , 61–63 and predictive validity, although none of these reported psychometrics were reported for those with cancer.64–67 Two studies have examined reliability of the MPQ in individuals with a cancer diagnosis.23 Both studies found that persons with cancer are generally consistent in the MPQ words they use to describe their pain from 1 week to the next.55 , 68 Reported MDC or MCID for this measure was unavailable, which could make it challenging to make clinical decisions based on the results. Normative scores have been reported for a variety of conditions including cancer and were 24% to 50% of the maximum scores for each part of the MPQ.69 The MPQ has been used in the following cancer diagnoses: breast, leukemia, lymphoma, lung, head and neck, and prostate.70 , 71 Clinical utility of the MPQ is diminished because of the time it takes to complete, scoring that is not intuitive, and no reported MDC or MCID. Ngamkham et al54 report that despite the large number of pain descriptors, some adults with a diagnosis of cancer found it difficult to describe their pain. Since the measure has good psychometric properties in those without cancer and has been used in a variety of studies in persons with cancer, it is therefore still a recommended measure.

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Pain Disability Index

EDGE Rating: 3 (Recommend). The Pain Disability Index (PDI) is a 7-item multidimensional self-report questionnaire designed to measure the disability of an individual due to his or her pain condition.72 The PDI asks individuals to rate the degree to which pain interferes with functioning in 7 broad areas: (1) family/home responsibilities, (2) recreation, (3) social activity, (4) occupation, (5) sexual behavior, (6) self-care, and (7) life support activity.73 Individuals are asked to rate their level of disability on a rating scale (0 = no disability to 10 = total disability).74 The PDI can be administered via telephone,75 via computer,76 or on paper. The PDI has been validated in those with low back pain,73 the general population,77 those with acute back pain, chronic low back pain, and widespread pain,78 and rheumatic patients with chronic pain.79

The PDI has been used in 3 cross-sectional studies in women with a diagnosis of breast cancer.79–82 Reliability of the PDI when administered to the general chronic pain population was 0.87 (Cronbach α).72 The PDI has been shown to have acceptable concurrent and construct validity in individuals with chronic pain.72 The PDI has a reported MCID of 6 points for individuals with low back pain.83 While the PDI was developed for patients with chronic pain from multiple causes, including cancer-related pain, published psychometrics for the PDI when administered to only a cancer population could not be found. The PDI has been used in individuals with breast and metastatic cancers. Since the measure has good psychometric properties in mixed chronic pain populations, it is therefore still a recommended measure.

A number of other pain measures were reviewed by the group and were not recommended (Table 5). The reasons included poor or absent psychometrics, outcome measures that were hard to understand, answer, or score, and/or outcome measures that have not been used in adults with a diagnosis of cancer.

TABLE 5

TABLE 5

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LIMITATIONS AND CONCLUSIONS

There are a variety of 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 15, 2016. For measures not 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 and could limit the number of measures reviewed. Researchers and clinicians are encouraged to review the Task Force recommendations, as well as each specific outcome measure, for more extensive information. While this article can serve as a guide, ultimately, it is up to clinicians and researchers to identify the best available evidence in addition to patient values and expectations in order to appropriately administer the correct pain outcome measure in the cancer population.84

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ACKNOWLEDGMENTS

The authors thank Sarah Foley, SPT, Megan Hass, SPT, and librarian John Mitchell, for their assistance with the literature search and EDGE forms.

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Keywords:

cancer; EDGE; outcome measure; pain

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