The validity and reliability of pain measures in adults with cancer
Open accessAbstract
To be most useful, clinical trials of cancer pain treatments should use pain measures that are both reliable and valid. A great variety of measures are now available that may be used to assess cancer pain. However, there are not yet any clear guidelines for selecting one or more measures over the others. The purpose of this article is to summarize the evidence concerning the validity and reliability of cancer pain measures. One hundred sixty-four articles were identified that provided psychometric data of pain measures among patients with cancer. The results indicate that commonly used single-item ratings of pain intensity are all valid and adequately reliable as measures of pain intensity, although some scales appear to be easier for patients with cancer to understand and to use than others. Multiple-item measures of pain intensity are reliable, but evidence concerning their validity is lacking. There is a paucity of research examining the psychometric properties of measures of cancer pain interference, pain relief, pain site, the temporal aspects of pain, and pain quality. This lack of evidence limits the conclusions that may be drawn concerning the reliability and validity of these other pain measures. Composite measures that combine ratings of pain intensity and pain interference into a single score appear to be both valid and reliable for describing patient populations, although their usefulness in clinical trials may be limited because they can obscure the contributions of intensity and interference to the total score. Proxy measures of cancer pain (pain ratings made by someone other than the patient) may be useful when patients are not able to provide pain ratings, but they should not be used as replacements for patient ratings when patient self-report measures are available. The discussion includes specific recommendations for selecting from among the available pain measures, as well as recommendations for future research into the assessment of cancer pain.
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The NRS has good reliability and validity as a measure of pain intensity and is less influenced by present mood state.
“In the context of pain, the NRS has been proven to have good reliability and validity [53,54]. It is a valid measure of pain intensity (0–10) that is less influenced by present mood state [55]”
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“The NRS is a valid and reliable measure of pain intensity (Jensen, 2003).”
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“Although considered valid (Chochinov et al., 1997; Jensen, 2003; McKenzie and Marks, 1999) one could ask why we should pay any attention to single items when these established scales did not show any gender differences.”
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“However, because the PPI is influenced by psychological factors at the moment (eg, current mood),(29) we also included an 11-point NRS, a valid measure of pain intensity less influenced by present mood state.(30) Finally, we assessed perceived pain burden during the previous week (11-point NRS).”
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“A descriptive NRS is a valid and reliable measure of pain intensity.(45) Because most patients in this study did not have pain, for the subsequent longitudinal analyses, pain was recoded as present or absent.”
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“The two scales formats have been chosen because they both have undergone specific validation studies in Italian and other languages [23,31,32] and fulfill the requirement of a sufficient number of levels to ensure scale sensitivity [22].”
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“A descriptive NRS is a valid and reliable measure of pain intensity.(21) 6.”
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“Validity and reliability of this methodology have undergone considerable evaluation [10], with few variations reported by sex or age [1–3].”
MethodRakel, B. A., Zimmerman, B. M., Geasland, K., Embree, J., Clark, C. R., Noiseux, N. O., Callaghan, J. J., Herr, K., Walsh, D., & Sluka, K. A. (2014) · Pain · doi:10.1016/j.pain.2014.09.025 · Cited by 115 · see citing works
“Previous studies have shown that the use of the NRS is associated with higher compliance and lower failure rates in older adults when compared to the visual analogue scale (VAS) [35], and has established validity and reliability for assessing acute [12,34,40,50] and postoperative [28] pain.”
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“[49] The advantage of NRS is that it can also be administered verbally in addition to visual method.”
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Dodd, M. J., Cho, M. H., Miaskowski, C. A., Painter, P., Paul, S. M., Cooper, B. A., Duda, J., Krasnoff, J. B., & Bank, K. A. (2010) · Cancer Nursing · doi:10.1097/ncc.0b013e3181ddc58c · Cited by 111 · see citing works
“A descriptive NRS is a valid and reliable measure of pain intensity.(76) The KPS Scale measures the physical abilities of the patient based on definitions provided using a 0- to 100-point scale.”
MethodMiaskowski, C. A., Paul, S. M., Cooper, B. A., West, C. M., Levine, J. D., Elboim, C., Hamolsky, D., Abrams, G., Luce, J. A., Dhruva, A., et al. (2014) · European Journal of Oncology Nursing · doi:10.1016/j.ejon.2013.12.002 · Cited by 109 · see citing works
Risk Stratification of Opioid Misuse among Patients with Cancer Pain Using the SOAPP-SF
Koyyalagunta, D., Bruera, E. D., Aigner, C. J., Harun, N., Driver, L., & Novy, D. M. (2013) · Pain Medicine · doi:10.1111/pme.12100 · Cited by 109 · see citing works
Pain Assessment Tools: Is the Content Appropriate for Use in Palliative Care?
Hølen, J. C., Hjermstad, M. J., Loge, J. H., Fayers, P. M., Caraceni, A. T., Conno, F. D., Forbes, K., Fürst, C. J., Radbruch, L., & Kaasa, S. (2006) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2006.05.025 · Cited by 109 · see citing works
Preoperative predictors of pain following total knee arthroplasty
Noiseux, N. O., Callaghan, J. J., Clark, C. R., Zimmerman, M. B., Sluka, K. A., & Rakel, B. A. (2014) · The Journal of Arthroplasty · doi:10.1016/j.arth.2014.01.034 · Cited by 109 · see citing works
“A 0–20 numerical rating scale (NRS) has established validity and reliability for assessing acute and postoperative pain [29–31].”
Symptom Assessment in Palliative Care: A Need for International Collaboration
Kaasa, S., Loge, J. H., Fayers, P. M., Caraceni, A. T., Strasser, F., Hjermstad, M. J., Higginson, I. J., Radbruch, L., & Haugen, D. F. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2007.15.8881 · Cited by 108 · see citing works
“In a recent systematic literature review, more than 40 different ways to measure pain intensity were identified.(21) Similar observations apply to the assessment of HRQOL in palliative care.”
MethodOnselen, C. V., Paul, S. M., Lee, K. A., Dunn, L. B., Aouizerat, B. E., West, C. M., Dodd, M. J., Cooper, B. A., & Miaskowski, C. A. (2012) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2012.02.020 · Cited by 103 · see citing works
Pain assessment tools in palliative care: an urgent need for consensus
Hjermstad, M. J., Gibbins, J. L., Haugen, D. F., Caraceni, A. T., Loge, J., & Kaasa, S. (2008) · Palliative Medicine · doi:10.1177/0269216308095701 · Cited by 103 · see citing works
Trajectories of Fatigue in Men with Prostate Cancer Before, During, and After Radiation Therapy
Miaskowski, C. A., Paul, S. M., Cooper, B. A., Lee, K. A., Dodd, M. J., West, C. M., Aouizerat, B. E., Swift, P. S., & Wara, W. (2008) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2007.07.007 · Cited by 103 · see citing works
“A descriptive numeric rating scale is a valid and reliable measure of pain intensity (17).”
BackgroundMethodAnalgesic effects of posthypnotic suggestions and virtual reality distraction on thermal pain
Patterson, D. R., Hoffman, H. G., Palacios, A. G., & Jensen, M. J. (2006) · Journal of Abnormal Psychology · doi:10.1037/0021-843x.115.4.834 · Cited by 100 · see citing works
Self-citationIs Pain Intensity a Predictor of the Complexity of Cancer Pain Management?
Fainsinger, R. L., Fairchild, A. M., Nekolaichuk, C., Lawlor, P. G., Lowe, S. S., & Hanson, J. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2008.17.1660 · Cited by 100 · see citing works
Galantino, M. L., Desai, K., Greene, L. A., DeMichele, A. M., Stricker, C. T., & Mao, J. J. J. (2011) · Integrative Cancer Therapies · doi:10.1177/1534735411413270 · Cited by 97 · see citing works
“95 in a sample of arthritis patients.(50,51) The BPI has high internal reliability and validity in adult cancer patients(51) and has been used to assess cancer pain, noncancer pain, complex regional pain syndrome, and osteoarthritis.”
BackgroundMethodINTERACTIVITY INFLUENCES THE MAGNITUDE OF VIRTUAL REALITY ANALGESIA.
Wender, R., Hoffman, H. G., Hunner, H. H., Seibel, E. J., Patterson, D. R., & Sharar, S. R. (2009) · PubMed · Cited by 95 · see citing works
PROMs for Pain in Adult Cancer Patients: A Systematic Review of Measurement Properties
Abahussin, A. A., West, R. M., Wong, D., & Ziegler, L. E. (2018) · Pain Practice · doi:10.1111/papr.12711 · Cited by 97 · see citing works
“Jensen (in 2003) conducted a review of the validity and reliability of pain measures for adult cancer patients, but it has several limitations.(39) The review was not systematic and is now outdated.”
Fretland, Å. A., Kazaryan, A. М., Bjørnbeth, B. A., Flatmark, K., Andersen, M. H., Tønnessen, T. I., Bjørnelv, G. M. W., Fagerland, M. W., Kristiansen, R., Øyri, K., et al. (2015) · Trials · doi:10.1186/s13063-015-0577-5 · Cited by 90 · see citing works
“The Numeric Rating Scale is closely correlated to the Visual Analogue Scale [45,46], and can be easier to complete for postoperative patients as it can be administered verbally.”
MethodDhruva, A., Paul, S. M., Cooper, B. A., Lee, K. A., West, C. M., Aouizerat, B. E., Dunn, L. B., Swift, P. S., Wara, W., & Miaskowski, C. A. (2012) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2011.08.010 · Cited by 92 · see citing works
“A descriptive NRS is a valid and reliable measure of pain intensity (35).”
BackgroundMcCann, B., Miaskowski, C. A., Koetters, T., Baggott, C., West, C. M., Levine, J. D., Elboim, C., Abrams, G., Hamolsky, D., Dunn, L. B., et al. (2012) · Journal of Pain · doi:10.1016/j.jpain.2011.02.358 · Cited by 91 · see citing works
“NRSs are valid and reliable measures of pain intensity.(31) Patients who completed Part 2were asked to complete Part 3.”
BackgroundPain sensitivity profiles in patients with advanced knee osteoarthritis
Frey‐Law, L., Bohr, N. L., Sluka, K. A., Herr, K., Clark, C. R., Noiseux, N. O., Callaghan, J. J., Zimmerman, M. B., & Rakel, B. A. (2016) · Pain · doi:10.1097/j.pain.0000000000000603 · Cited by 91 · see citing works
“Some college 9 (25) 21 (26) 13 (37) 4 (10) 7 (70)”
Weiss, B., Widemann, B. C., Wolters, P. L., Dombi, E., Vinks, A. A. T. M. M., Cantor, A. B., Korf, B. R., Perentesis, J. P., Gutmann, D. H., Schorry, E. K., et al. (2013) · Pediatric Blood & Cancer · doi:10.1002/pbc.24873 · Cited by 89 · see citing works
“VAS ratings are reliable and valid measures of pain intensity in both children [28] and adults [29].”
BackgroundJi, Y., Bo, C., Xue, X.-J., Weng, E., Gao, G., Dai, B., Ding, K., & Xu, C. (2017) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2017.05.003 · Cited by 89 · see citing works
Effect of music therapy on pain and anxiety levels of cancer patients: A pilot study
Krishnaswamy, P., & Nair, S. (2016) · Indian Journal of Palliative Care · doi:10.4103/0973-1075.185042 · Cited by 89 · see citing works
Chien, C.-W., Bagraith, K. S., Khan, A., Deen, M., & Strong, J. (2013) · The Journal of Pain · doi:10.1016/j.jpain.2013.08.006 · Cited by 108 · see citing works
ORANGE II Study Group, van Dam, R. M., Wong‐Lun‐Hing, E. M., van Breukelen, G., Stoot, J. H. M. B., van der Vorst, J. R., Bemelmans, M. H. A., Damink, S. W. M. O., Lassen, K., & Dejong, C. H. C. (2012) · Trials · doi:10.1186/1745-6215-13-54 · Cited by 80 · see citing works
“Postoperative pain will be systematically registered twice daily using the validated verbally administered 11-point numeric rating scale (NRS-11, 0 to 10) [50-53].”
BackgroundMethodTrajectories of fear of recurrence in women with breast cancer
Dunn, L. B., Langford, D. J., Paul, S. M., Berman, M., Shumay, D. M., Kober, K. M., Merriman, J. D., West, C. M., Neuhaus, J. M., & Miaskowski, C. A. (2014) · Supportive Care in Cancer · doi:10.1007/s00520-014-2513-8 · Cited by 81 · see citing works
“Numeric Rating scales are valid and reliable measures of pain intensity [46].”
Williams, V. S. L., Smith, M. Y., & Fehnel, S. E. (2006) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2005.06.008 · Cited by 79 · see citing works
Hunt, A., Wisbeach, A., Seers, K., Goldman, A., Crichton, N., Perry, L., & Mastroyannopoulou, K. (2007) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2006.08.011 · Cited by 78 · see citing works
Harris, K., Li, K., Flynn, C., & Chow, E. (2007) · Clinical Oncology · doi:10.1016/j.clon.2007.04.007 · Cited by 77 · see citing works
Sillevis, R., Cleland, J. A., Hellman, M. A., & Beekhuizen, K. (2010) · Journal of Manual & Manipulative Therapy · doi:10.1179/106698110x12804993427126 · Cited by 74 · see citing works
Ruskin, D. A., Lalloo, C., Amaria, K., Stinson, J., Kewley, E., Campbell, F. A., Brown, S. C., Jeavons, M., & McGrath, P. A. (2014) · Pain Research and Management · doi:10.1155/2014/856513 · Cited by 76 · see citing works
“The NRS has been recommended in the consensus Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (Ped-IMMPACT) statement (39) as a core outcome measure for clinical trials on pain in adults due to its versatility, ease of administration, and concurrent validity with VASs (40,41) – alt…”
BackgroundCharalambous, A., Giannakopoulou, M., Bozas, E., & Paikousis, L. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-026809 · Cited by 70 · see citing works
“Within the cancer context, NRS used to assess the intensity of pain have a proven validity and reliability.(11) The Cancer Fatigue Scale (CFS)(12) was used to assess the participants’ levels of fatigue.”
MethodHereditary Multiple Exostosis and Pain
Darilek, S. A., Wicklund, C. L., Novy, D. M., Scott, A., Gambello, M. J., Johnston, D. A., & Hecht, J. T. (2005) · Journal of Pediatric Orthopaedics · doi:10.1097/01.bpo.0000150813.18673.ad · Cited by 72 · see citing works
Measuring Pain Intensity in Nursing Home Residents
Jones, K. R., Fink, R. M., Hutt, E., Vojir, C. P., Pepper, G. A., Scott‐Cawiezell, J., & Mellis, B. K. (2005) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2005.05.020 · Cited by 69 · see citing works
“Faces Pain Scale (FPS) are the most commonly used tools for measuring pain intensity(22,23) and have been shown to be valid and sensitive in general populations.(16,24) These tools have also established validity and reliability as options for assessing pain intensity in older adults, including some with mild-to-modera…”
MethodKnudsenl, A. K., Brunelli, C., Kaasal, S., Apolone, G., Corlil, O., Montanaril, M., Fainsingerl, R., Aassl, N., Fayers, P. M., Caraceni, A. T., et al. (2010) · European Journal of Pain · doi:10.1016/j.ejpain.2010.08.001 · Cited by 70 · see citing works
Felix, E. R., Cruz‐Almeida, Y., & Widerström-Noga, E. G. (2007) · The Journal of Rehabilitation Research and Development · doi:10.1682/jrrd.2006.12.0162 · Cited by 70 · see citing works
“The unpleasantness rating was removed from the regression analysis, since pain intensity is more commonly used in the literature as an outcome measure for pain [52–53].”
MethodLitterini, A. J., Fieler, V. K., Cavanaugh, J. T., & Lee, J. Q. (2013) · Archives of Physical Medicine and Rehabilitation · doi:10.1016/j.apmr.2013.06.008 · Cited by 69 · see citing works
Riddle, D. L., & Stratford, P. W. (2013) · Lara D. Veeken · doi:10.1093/rheumatology/ket291 · Cited by 69 · see citing works
BREAST CANCER EDGE TASK FORCE OUTCOMES: Clinical Measures of Pain
Harrington, S., Gilchrist, L. S., & Sander, A. P. (2014) · Rehabilitation Oncology · doi:10.1097/01893697-201432010-00004 · Cited by 68 · see citing works
Hoffman, H. G. (2021) · Scientific Reports · doi:10.1038/s41598-021-89526-4 · Cited by 67 · see citing works
Stephens, K., Cooper, B. A., West, C. M., Paul, S. M., Baggott, C., Merriman, J. D., Dhruva, A., Kober, K. M., Langford, D. J., Leutwyler, H. C., et al. (2013) · Journal of Pain · doi:10.1016/j.jpain.2013.09.015 · Cited by 66 · see citing works
“An NRS is a valid and reliable measure of pain intensity.(32) The Postsurgical Pain Questionnaire evaluated pain intensity in the first 24 to 48 hours after surgery.”
MethodEffect of cryotherapy on arteriovenous fistula puncture-related pain in hemodialysis patients
Mahajan, S., Sabitha, P., KHAKHA, D. C., Gupta, S., Agarwal, M., & Yadav, S. (2008) · Indian Journal of Nephrology · doi:10.4103/0971-4065.45290 · Cited by 66 · see citing works
Kaasa, S., Apolone, G., Klepstad, P., Loge, J. H., Hjermstad, M. J., Corli, O., Strasser, F., Heiskanen, T., Costantini, M., Zagonel, V., et al. (2011) · BMJ Supportive & Palliative Care · doi:10.1136/bmjspcare-2011-000078 · Cited by 66 · see citing works
Self-citationFlores, A., Linehan, M. M., Todd, S. R., & Hoffman, H. G. (2018) · Frontiers in Psychology · doi:10.3389/fpsyg.2018.00531 · Cited by 64 · see citing works
“The current study introduces new measures using a Graphic Rating Scales question format (Jensen, 2003).”
MethodKwekkeboom, K. L., Hau, H., Wanta, B., & Bumpus, M. (2008) · Complementary Therapies in Clinical Practice · doi:10.1016/j.ctcp.2008.04.002 · Cited by 65 · see citing works
“Numeric ratings scales are widely used in pain research and acknowledged as reliable, valid measures of pain intensity [30].”
BackgroundPrice, D. D., Patel, R. K., Robinson, M. E., & Staud, R. M. (2008) · Pain · doi:10.1016/j.pain.2008.07.028 · Cited by 65 · see citing works
“of their use in acute pain settings generally find that the standard pencil-and-paper VAS requires greater cognitive capacity as well as motor skills and is more prone to errors than NUM [7,8].”
BackgroundMiaskowski, C., Paul, S. M., Cooper, B. A., Lee, K., Dodd, M., West, C., Aouizerat, B. E., Dunn, L., Swift, P. S., & Wara, W. (2011) · Sleep · doi:10.1093/sleep/34.2.171 · Cited by 64 · see citing works
Johnson, C. D., Berry, D. P., Harris, S., Pickering, R. M., Davis, C., George, S., IMRIE, C. W., Neoptolemos, J. P., & Sutton, R. (2009) · Pancreatology · doi:10.1159/000199441 · Cited by 64 · see citing works
Reyes‐Gibby, C. C., Swartz, M. D., Yu, X., Wu, X., Yennurajalingam, S., Anderson, K. O., Spitz, M. R., & Shete, S. S. (2013) · Supportive Care in Cancer · doi:10.1007/s00520-013-1885-5 · Cited by 62 · see citing works
“However, although multiple items may be preferred, studies have shown that symptoms measured by a single item correlate highly with multi-item measures of pain, fatigue, and depression [41, 42].”
Alexithymia and cancer pain: the effect of psychological intervention
Tulipani, C., Morelli, F., Spedicato, M. R., Maiello, E., Todarello, O., & Porcelli, P. (2010) · Psychotherapy and Psychosomatics · doi:10.1159/000286960 · Cited by 61 · see citing works
“To avoid multiple redundant associations, the following 3 pain dimensions were selected: intensity of pain (perceived level of pain ranging from 0 to 10), interference of pain (averaged score of 7 daily living functions – general activity, mood, walking ability, normal work, interpersonal relationships, sleep, and enj…”
MethodEfetividade da acupuntura auricular no tratamento da dor oncológica: ensaio clínico randomizado
Ruela, L. D. O., Iunes, D. H., Nogueira, D. A., Stefanello, J., & Gradim, C. V. C. (2018) · Revista da Escola de Enfermagem da USP · doi:10.1590/s1980-220x2017040503402 · Cited by 61 · see citing works
“Pain intensity was evaluated in the first and ninth meetings, using the 11-point version of the EN, chosen because of its reliability in evaluating cancer pain(20).”
MethodSayın, Y., & Akyolcu, N. (2012) · Pain Management Nursing · doi:10.1016/j.pmn.2012.08.005 · Cited by 61 · see citing works
“It is difficult to choose the most suitable pain scale for a given clinical setting (G elinas, Loiselle, LeMay, Ranger, Bouchard, & McCormack, 2008; Jensen, 2003).”
BackgroundAlexithymia, coping, and illness behavior correlates of pain experience in cancer patients
Porcelli, P., Tulipani, C., Maiello, E., Cilenti, G., & Todarello, O. (2006) · Psycho-Oncology · doi:10.1002/pon.1115 · Cited by 61 · see citing works
“The average value of responses given to each adjective was considered as the mean pain quality score for each patient [35].”
Does binge drinking in teenagers affect their everyday prospective memory?
Heffernan, T., Clark, R., Bartholomew, J., Ling, J., & Stephens, S. (2010) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2009.12.013 · Cited by 60 · see citing works
Virtual reality analgesia for burn joint flexibility: A randomized controlled trial.
Soltani, M., Drever, S. A., Hoffman, H. G., Sharar, S. R., WIECHMAN, S. A., Jensen, M. P., & Patterson, D. R. (2018) · Rehabilitation Psychology · doi:10.1037/rep0000239 · Cited by 59 · see citing works
“Evidence supports the reliability and validity of GRSs for detecting changes in these pain domains over time (Gracely, McGrath, & Dubner, 1978; Jensen, 2003; Jensen & Karoly, 1992).”
Self-citationLuckett, T., & King, M. T. (2010) · European Journal of Cancer · doi:10.1016/j.ejca.2010.08.002 · Cited by 60 · see citing works
- Authors
- Jensen, M. P.
- Affiliations
- University of Washington (US)
- Corresponding author
- Jensen, Mark P.
- ORCID
- Jensen, Mark P.
- Venue
- The Journal of Pain
- Publisher
- Elsevier BV
- Published
- 2003-02
- Volume
- 4
- Issue
- 1
- Pages
- 2-21
- ISSN
- 1526-5900 (ISSN-L)
- OpenAlex
- W1969092046
- Cited by
- 427
- References
- 28
- Citations by year
- 2026: 4 · 2025: 6 · 2024: 18 · 2023: 10 · 2022: 13 · 2021: 26 · 2020: 18 · 2019: 12 · 2018: 24 · 2017: 20 · 2016: 18 · 2015: 22 · 2014: 25 · 2013: 30 · 2012: 31
- FWCI
- 10.45
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Pain (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pediatric Pain Management Techniques
- Keywords
- cancer pain, pain assessment, psychometric properties, validity, reliability statistics, pain intensity, pain interference, analgesia, patient self-report, clinical trial outcome measures
- MeSH terms
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Female, Humans, Male, Middle Aged, Neoplasms, Pain, Pain Measurement, Reproducibility of Results
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