Advertisement

I. Indices of Pain Intensity Derived From Ecological Momentary Assessments: Rationale and Stakeholder Preferences

Published:September 14, 2020DOI:https://doi.org/10.1016/j.jpain.2020.08.003

      HIGHLIGHTS

      • We introduce several indices of pain intensity that can be derived from EMA.
      • Patients, providers, and clinical trialists were interviewed about the EMA indices.
      • Each stakeholder group had a distinct preference hierarchy for different indices.
      • Multiple temporal characteristics of pain intensity are relevant for stakeholders.

      Abstract

      Pain assessment that fully represents patients’ pain experiences is essential for chronic pain research and management. The traditional primary outcome measure has been a patient's average pain intensity over a time period. In this series of 3 articles, we examine whether pain assessment can be enhanced by considering additional outcome measures capturing temporal aspects of pain, such as pain maxima, duration, and variability. Ecological momentary assessment makes the assessment of such indices readily available. In this first article, we discuss the rationale for considering additional pain indices derived from ecological momentary assessment and examine which are most important to stakeholders. Patients (n = 32), clinicians (n = 20), and clinical trialists (n = 20) were interviewed about their preference rankings for Average, Worst, and Least Pain, Time in High Pain, Time in No/Low Pain, Pain Variability, and Pain Unpredictability. Each stakeholder group displayed a distinct preference hierarchy for different indices, and there were few commonalities between groups. Patients favored Worst Pain and Time in High Pain, followed by Pain Variability and Unpredictability. Trialists favored Average Pain, whereas clinicians favored Worst Pain. Results suggest that multiple temporal aspects of pain are relevant for stakeholders and should be considered when evaluating the efficacy of pain management.

      Perspective

      Examining which aspects of pain are most important to measure from the perspective of different stakeholders can facilitate efforts to include all relevant treatment outcomes. Our study suggests that multiple temporal aspects of pain intensity are important to stakeholders. This should be considered when evaluating the efficacy of pain management.

      Key words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to The Journal of Pain
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Affleck G
        • Tennen H
        • Urrows S
        • Higgins P
        Individual differences in the day-to-day experience of chronic pain: A prospective daily study of rheumatoid arthritis patients.
        Health Psychol. 1991; 10: 419-426
        • Agiostratidou G
        • Anhalt H
        • Ball D
        • Blonde L
        • Gourgari E
        • Harriman KN
        • Kowalski AJ
        • Madden P
        • McAuliffe-Fogarty AH
        • McElwee-Malloy M
        Standardizing clinically meaningful outcome measures beyond HbA1c for type 1 diabetes: A consensus report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange.
        Diabetes Care. 2017; 40: 1622-1630
        • Allen K
        • Bosworth H
        • Coffman C
        • Jeffreys A
        • Oddone E
        • Yancy W
        Associations of frequent predictable and unpredictable pain with functional and psychological outcomes.
        Osteoarthrit Cartil. 2013; 21: S263-S264
        • Allen KD
        The value of measuring variability in osteoarthritis pain.
        J Rheumatol. 2007; 34: 2132-2133
        • Allison PD
        • Christakis N
        Logit models for sets of ranked items.
        in: Marsden PV Sociological Methodology. 24. Blackwell, Oxford1994: 123-126
        • Boonstra AM
        • Preuper HRS
        • Balk GA
        • Stewart RE
        Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain.
        PAIN. 2014; 155: 2545-2550
        • Broderick JE
        • Schwartz JE
        • Vikingstad G
        • Pribbernow M
        • Grossman S
        • Stone AA
        The accuracy of pain and fatigue items across different reporting periods.
        Pain. 2008; 139: 146-157
        • Casarett D
        • Karlawish J
        • Sankar P
        • Hirschman K
        • Asch DA
        Designing pain research from the patient's perspective: What trial end points are important to patients with chronic pain?.
        Pain Med. 2001; 2: 309-316
        • Cella D
        • Riley W
        • Stone A
        • Rothrock N
        • Reeve B
        • Yount S
        • Amtmann D
        • Bode R
        • Buysse D
        • Choi S
        • Cook K
        • DeVellis R
        • DeWalt D
        • Fries JF
        • Gershon R
        • Hahn EA
        • Lai J-S
        • Pilkonis P
        • Revicki D
        • Rose M
        • Weinfurt K
        • Hays R
        The patient-reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008.
        J Clin Epidemiol. 2010; 63: 1179-1194
        • Cheung MW-L
        • Chan W
        Reducing uniform response bias with ipsative measurement in multiple-group confirmatory factor analysis.
        Struct Equation Model. 2002; 9: 55-77
        • Cleeland CS
        • Ryan KM
        Pain assessment: Global use of the brief pain inventory.
        Ann Acad Med Singapore. 1994; 23: 129-138
        • Craig BM
        • Busschbach JJ
        • Salomon JA
        Modeling ranking, time trade-off and visual analogue scale values for EQ-5D health states: A review and comparison of methods.
        Med Care. 2009; 47: 634-641
        • de Wit M
        • Abma T
        • Koelewijn-van Loon M
        • Collins S
        • Kirwan J
        Involving patient research partners has a significant impact on outcomes research: A responsive evaluation of the international OMERACT conferences.
        BMJ Open. 2013; 3e002241
        • Dirksen CD
        The use of research evidence on patient preferences in health care decision-making: Issues, controversies and moving forward.
        Expert Rev Pharmacoecon Outcomes Res. 2014; 14: 785-794
        • Dworkin RH
        • Turk DC
        • Farrar JT
        • Haythornthwaite JA
        • Jensen MP
        • Katz NP
        • Kerns RD
        • Stucki G
        • Allen RR
        • Bellamy N
        • Carr DB
        • Chandler J
        • Cowan P
        • Dionne R
        • Galer BS
        • Hertz S
        • Jadad AR
        • Kramer LD
        • Manning DC
        • Martin S
        • McCormick CG
        • McDermott MP
        • McGrath P
        • Quessy S
        • Rappaport BA
        • Robbins W
        • Robinson JP
        • Rothman M
        • Royal MA
        • Simon L
        • Stauffer JW
        • Stein W
        • Tollett J
        • Wernicke J
        • Witter J
        Core outcome measures for chronic pain clinical trials: IMMPACT recommendations.
        Pain. 2005; 113: 9-19
        • Fillingim RB
        • Loeser JD
        • Baron R
        • Edwards RR
        Assessment of chronic pain: Domains, methods, and mechanisms.
        J Pain. 2016; 17: T10-T20
        • Frank L
        • Basch E
        • Selby JV
        The PCORI perspective on patient-centered outcomes research.
        JAMA. 2014; 312: 1513-1514
        • Gobo G
        Sampling, representativeness and generalizability.
        (editors)in: Seale C Gobo G Gubrium JF Silverman D Qualitative Research Practice. SAGE Publications Ltd, London2004: 405-426
        • Harris RE
        • Williams DA
        • McLean SA
        • Sen A
        • Hufford M
        • Gendreau RM
        • Gracely RH
        • Clauw DJ
        Characterization and consequences of pain variability in individuals with fibromyalgia.
        Arthritis Rheum. 2005; 52: 3670-3674
        • Houben M
        • Van Den Noortgate W
        • Kuppens P
        The relation between short-term emotion dynamics and psychological well-being: A meta-analysis.
        Psychol Bull. 2015; 141: 901-930
        • Hultsch DF
        • MacDonald SW
        • Dixon RA
        Variability in reaction time performance of younger and older adults.
        J Gerontol Series B Psychologic Sci Soc Sci. 2002; 57: P101-P115
        • Jensen MP
        • Karoly P
        Self-report scales and procedures for assessing pain in adults.
        in: Turk DC Melzack R Handbook of Pain Assessment. Guilford Press, New York2001: 15-34
        • Jensen MP
        • McFarland CA
        Increasing the reliability and validity of pain intensity measurement in chronic pain patients.
        Pain. 1993; 55: 195-203
        • Kikuchi H
        • Yoshiuchi K
        • Miyasaka N
        • Ohashi K
        • Yamamoto Y
        • Kumano H
        • Kuboki T
        • Akabayashi A
        Reliability of recalled self-report on headache intensity: investigation using ecological momentary assessment technique.
        Cephalalgia. 2006; 26: 1335-1343
        • Kirwan JR
        • de Wit M
        Patients as partners: Building on the experience of Outcome Measures in Rheumatology (OMERACT).
        Arthritis Rheumatol. 2016; 68: 1334-1336
        • Krishna S
        • Boren SA
        • Balas EA
        Healthcare via cell phones: A systematic review.
        Telemed e-Health. 2009; 15: 231-240
        • Krueger AB
        • Stone AA
        Assessment of pain: A community-based diary survey in the USA.
        Lancet. 2008; 371: 1519-1525
        • Litcher-Kelly L
        • Martino SA
        • Broderick JE
        • Stone AA
        A systematic review of measures used to assess chronic musculoskeletal pain in clinical and randomized controlled clinical trials.
        J Pain. 2007; 8: 906-913
        • Marden JI
        Analyzing and Modeling Rank Data.
        Chapman & Hall, London1995
        • Matthews CE
        • Chen KY
        • Freedson PS
        • Buchowski MS
        • Beech BM
        • Pate RR
        • Troiano RP
        Amount of time spent in sedentary behaviors in the United States, 2003–2004.
        Am J Epidemiol. 2008; 167: 875-881
        • May M
        • Junghaenel DU
        • Ono M
        • Stone AA
        • Schneider S
        Ecological momentary assessment methodology in chronic pain research: A systematic review.
        J Pain. 2018; 19: 699-716
        • Meulders A
        • Vansteenwegen D
        • Vlaeyen JW
        Women, but not men, report increasingly more pain during repeated (un) predictable painful electrocutaneous stimulation: Evidence for mediation by fear of pain.
        PAIN. 2012; 153: 1030-1041
        • Moseley GL
        • Brhyn L
        • Ilowiecki M
        • Solstad K
        • Hodges PW
        The threat of predictable and unpredictable pain: Differential effects on central nervous system processing?.
        Aust J Physiother. 2003; 49: 263-267
        • Pai Y-W
        • Lin C-H
        • Lee I-T
        • Chang M-H
        Variability of fasting plasma glucose and the risk of painful diabetic peripheral neuropathy in patients with type 2 diabetes.
        Diabetes Metab. 2018; 44: 129-134
        • Parati G
        • Ochoa JE
        • Lombardi C
        • Bilo G
        Assessment and management of blood-pressure variability.
        Nat Rev Cardiol. 2013; 10: 143-155
        • Ram N
        • Gerstorf D
        Time-structured and net intraindividual variability: Tools for examining the development of dynamic characteristics and processes.
        Psychol Aging. 2009; 24: 778-791
        • Robinson ME
        • Brown JL
        • George SZ
        • Edwards PS
        • Atchison JW
        • Hirsh AT
        • Waxenberg LB
        • Wittmer V
        • Fillingim RB
        Multidimensional success criteria and expectations for treatment of chronic pain: The patient perspective.
        Pain Med. 2005; 6: 336-345
      1. Schneider S, Junghaenel DU, Broderick JE, Ono M, May M, Stone AA: Indices of pain intensity derived from ecological momentary assessments and their relationships with patient functioning: An individual patient data meta-analysis. J Pain, (under review).

        • Schneider S
        • Junghaenel DU
        • Keefe FJ
        • Schwartz JE
        • Stone AA
        • Broderick JE
        Individual differences in the day-to-day variability of pain, fatigue, and well-being in patients with rheumatic disease: Associations with psychological variables.
        Pain. 2012; 153: 813-822
      2. Schneider S, Junghaenel DU, Ono M, Broderick JE, Stone AA: Detecting treatment effects in clinical trials with different indices of pain intensity derived from ecological momentary assessment. J Pain, (under review)

        • Schneider S
        • Junghaenel DU
        • Ono M
        • Stone AA
        Temporal dynamics of pain: An application of regime-switching models to ecological momentary assessments in patients with rheumatic diseases.
        Pain. 2018; 159: 1346-1358
        • Schneider S
        • Stone AA
        Distinguishing between frequency and intensity of health-related symptoms from diary assessments.
        J Psychosom Res. 2014; 77: 205-212
        • Schneider S
        • Stone AA
        Ambulatory and diary methods can facilitate the measurement of patient-reported outcomes.
        Qual Life Res. 2016; 25: 497-506
        • Selby JV
        • Beal AC
        • Frank L
        The Patient-Centered Outcomes Research Institute (PCORI) national priorities for research and initial research agenda.
        JAMA. 2012; 307: 1583-1584
        • Selby JV
        • Forsythe L
        • Sox HC
        Stakeholder-driven comparative effectiveness research: An update from PCORI.
        JAMA. 2015; 314: 2235-2236
        • Smith SM
        • Hunsinger M
        • McKeown A
        • Parkhurst M
        • Allen R
        • Kopko S
        • Lu Y
        • Wilson HD
        • Burke LB
        • Desjardins P
        Quality of pain intensity assessment reporting: ACTTION systematic review and recommendations.
        J Pain. 2015; 16: 299-305
        • Smith SM
        • Jensen MP
        • He H
        • Kitt R
        • Koch J
        • Pan A
        • Burke LB
        • Farrar JT
        • McDermott MP
        • Turk DC
        A Comparison of the assay sensitivity of average and worst pain intensity in pharmacologic trials: An action systematic review and meta-analysis.
        J Pain. 2018; 19: 953-960
        • Smith WR
        • Bauserman RL
        • Ballas SK
        • McCarthy WF
        • Steinberg MH
        • Swerdlow PS
        • Waclawiw MA
        • Barton BA
        • Hydro IMS
        Climatic and geographic temporal patterns of pain in the multicenter study of hydroxyurea.
        Pain. 2009; 146: 91-98
        • Stone AA
        • Broderick JE
        • Schneider S
        • Schwartz JE
        Expanding options for developing outcome measures from momentary assessment data.
        Psychosom Med. 2012; 74: 387-397
        • Stone AA
        • Broderick JE
        • Schwartz JE
        Validity of average, minimum, and maximum end-of-day recall assessments of pain and fatigue.
        Contemp Clin Trials. 2010; 31: 483-490
        • Stone AA
        • Broderick JE
        • Shiffman SS
        • Schwartz JE
        Understanding recall of weekly pain from a momentary assessment perspective: Absolute agreement, between- and within-person consistency, and judged change in weekly pain.
        Pain. 2004; 107: 61-69
        • Stone AA
        • Schwartz JE
        • Broderick JE
        • Shiffman SS
        Variability of momentary pain predicts recall of weekly pain: A consequence of the peak (or salience) memory heuristic.
        Pers Soc Psychol Bull. 2005; 31: 1340-1346
        • Stone AA
        • Shiffman S
        Ecological momentary assessment (EMA) in behavorial medicine.
        Ann Behav Med. 1994; 16: 199-202
        • Tracy LM
        • Ioannou L
        • Baker KS
        • Gibson SJ
        • Georgiou-Karistianis N
        • Giummarra MJ
        Meta-analytic evidence for decreased heart rate variability in chronic pain implicating parasympathetic nervous system dysregulation.
        Pain. 2016; 157: 7-29
        • Turk DC
        • Dworkin RH
        • Revicki D
        • Harding G
        • Burke LB
        • Cella D
        • Cleeland CS
        • Cowan P
        • Farrar JT
        • Hertz S
        Identifying important outcome domains for chronic pain clinical trials: An IMMPACT survey of people with pain.
        PAIN. 2008; 137: 276-285
        • US Department of Health and Human Services Food and Drug Administration
        Guidance for Industry: Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.
        2009 (Available at:) (Accessed September 3, 2018)
        • US Department of Health and Human Services Food and Drug Administration
        Guidance for Industry: Analgesic Indications: Developing Drug and Biological Products.
        2014 (Available at) (Accessed April 26, 2019)
        • Werner A
        • Malterud K
        It is hard work behaving as a credible patient: Encounters between women with chronic pain and their doctors.
        Soc Sci Med. 2003; 57: 1409-1419
        • Williamson P
        • Altman D
        • Blazeby J
        • Clarke MJ
        • Gargon E
        The COMET (Core Outcome Measures in Effectiveness Trials) initiative.
        Trials. 2011; 12: A70
        • Zakoscielna KM
        • Parmelee PA
        Pain variability and its predictors in older adults: Depression, cognition, functional status, health, and pain.
        J Aging Health. 2013; 25: 1329-1339