Initial Content Validation and Roadmap for a New Patient-Reported Outcome Measure of Pain Intensity


      • Substantial variability exists in how patients are asked to rate pain intensity.
      • Measures based on patient input may be more valid and meaningful.
      • This study describes the initial development of pain intensity measures.
      • Procedures aligned with US FDA's Clinical Outcome Assessment Qualification Program.
      • Measures will be further evaluated in cognitive interviews and quantitative studies.


      Measures of pain intensity (eg, numeric rating scales [NRS]) are widely used in clinical research and practice. While these measures have evidence for validity and reliability, poor standardization of instructions, and response options limits precision of pain assessment, allows for inconsistency in interpretation, and presents a challenge for comparison and aggregation of study results. Despite these pitfalls, the 0 to 10 NRS remains the most commonly used primary outcome measure in clinical trials of pain treatments and is the core measure recommended by regulatory agencies. The purpose of this study was to describe the first phase in the development of a pain intensity measure that is easily interpretable, psychometrically sound, and that adheres to FDA qualification processes. The Analgesic, Anesthetic, and Addiction Clinical Trial, Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership conducted concept elicitation interviews (N = 44; 22 with acute pain; 22 with chronic pain) to understand the patient perspective on rating pain intensity and to identify actionable suggestions for improved clarity and meaningfulness of instructions, recall periods, and response options. This article summarizes interview findings, describes how patient input and FDA feedback informed preliminary candidate measures, and provides an overview of the FDA qualification process.


      Concept elicitation interviews informed the development of content-valid candidate measures of acute and chronic pain intensity for planned use in clinical trials of pain treatments, and comprise the initial stage in FDA clinical outcome assessment qualification. Measures will subsequently be evaluated through cognitive interviews and a series of psychometric studies.

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


        • Amtmann D.
        • Cook K.F.
        • Jensen M.P.
        • Chen W.H.
        • Choi S.
        • Revicki D.
        • Cella D.
        • Rothrock N.
        • Keefe F.
        • Callahan L.
        • Lai J.S.
        Development of a PROMIS item bank to measure pain interference.
        Pain. 2010; 150: 173-182
        • Ballantyne J.C.
        • Sullivan M.D.
        Intensity of chronic pain–the wrong metric?.
        N Engl J Med. 2015; 373: 2098-2099
        • Broderick J.E.
        • Stone A.A.
        • Calvanese P.
        • Schwartz J.E.
        • Turk D.C.
        Recalled pain ratings: A complex and poorly defined task.
        J Pain. 2006; 7: 142-149
        • Buckenmaier C.C.
        • Galloway K.T.
        • Polomano R.C.
        • McDuffie M.
        • Kwon N.
        • Gallagher R.M.
        Preliminary validation of the Defense and Veterans Pain Rating Scale (DVPRS) in a military population.
        Pain Med. 2013; 14: 110-123
        • Bushnell D.M.
        • McCarrier K.P.
        • Bush E.N.
        • Abraham L.
        • Jamieson C.
        • McDougall F.
        • Trivedi M.H.
        • Thase M.E.
        • Carpenter L.
        • Coons S.J.
        • Group PROCsDW
        Symptoms of major depressive disorder scale: Performance of a novel patient-reported symptom measure.
        Value Health. 2019; 22: 906-915
        • Chiarotto A.
        • Boers M.
        • Deyo R.A.
        • Buchbinder R.
        • Corbin T.P.
        • Costa L.O.P.
        • Foster N.E.
        • Grotle M.
        • Koes B.W.
        • Kovacs F.M.
        • Lin C.C.
        • Maher C.G.
        • Pearson A.M.
        • Peul W.C.
        • Schoene M.L.
        • Turk D.C.
        • van Tulder M.W.
        • Terwee C.B.
        • Ostelo R.W.
        Core outcome measurement instruments for clinical trials in nonspecific low back pain.
        Pain. 2018; 159: 481-495
        • Clement R.C.
        • Welander A.
        • Stowell C.
        • Cha T.D.
        • Chen J.L.
        • Davies M.
        • Fairbank J.C.
        • Foley K.T.
        • Gehrchen M.
        • Hagg O.
        • Jacobs W.C.
        • Kahler R.
        • Khan S.N.
        • Lieberman I.H.
        • Morisson B.
        • Ohnmeiss D.D.
        • Peul W.C.
        • Shonnard N.H.
        • Smuck M.W.
        • Solberg T.K.
        • Stromqvist B.H.
        • Hooff M.L.
        • Wasan A.D.
        • Willems P.C.
        • Yeo W.
        • Fritzell P.
        A proposed set of metrics for standardized outcome reporting in the management of low back pain.
        Acta Orthop. 2015; 86: 523-533
        • de Williams A.C.
        • Davies H.T.O.
        • Chadury Y.
        Simple pain rating scales hide complex idiosyncratic meanings.
        Pain. 2000; 85: 457-463
        • Dworkin R.H.
        • Turk D.C.
        • Farrar J.T.
        • Haythornthwaite J.A.
        • Jensen M.P.
        • Katz N.P.
        • Kerns R.D.
        • Stucki G.
        • Allen R.R.
        • Bellamy N.
        • Carr D.B.
        • Chandler J.
        • Cowan P.
        • Dionne R.
        • Galer B.S.
        • Hertz S.
        • Jadad A.R.
        • Kramer L.D.
        • Manning D.C.
        • Martin S.
        • McCormick C.G.
        • McDermott M.P.
        • McGrath P.
        • Quessy S.
        • Rappaport B.A.
        • Robbins W.
        • Robinson J.P.
        • Rothman M.
        • Royal M.A.
        • Simon L.
        • Stauffer J.W.
        • Stein W.
        • Tollett J.
        • Wernicke J.
        • Witter J.
        Immpact. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations.
        Pain. 2005; 113: 9-19
      1. European Medicines Agency: Qualification of Novel Methodologies for Drug Development: Guidance to Applicants, Amsterdam, The Netherlands, 2020

        • Fillingim R.B.
        Individual differences in pain: understanding the mosaic that makes pain personal.
        Pain. 2017; 158: S11-S18
        • Griffin R.S.
        • Antoniak M.
        • Mac P.D.
        • Kramskiy V.
        • Waldman S.
        • Mimno D.
        Imagined examples of painful experiences provided by chronic low back pain patients and attributed a pain numerical rating score.
        Front Neurosci. 2019; 13: 1331
        • Hjermstad M.J.
        • Fayers P.M.
        • Haugen D.F.
        • Caraceni A.
        • Hanks G.W.
        • Loge J.H.
        • Fainsinger R.
        • Aass N.
        • Kaasa S.
        • European Palliative Care Research C
        Studies comparing numerical rating scales, verbal rating scales, and visual analogue scales for assessment of pain intensity in adults: a systematic literature review.
        J Pain Symptom Manage. 2011; 41: 1073-1093
        • Jensen M.P.
        • Karoly P.
        Self-report scales and procedures for assessing pain in adults.
        in: Turk D.C. Melzack R. Handbook of pain assessment. The Guilford Press, New York2011: 19-44 (Eds.)
        • McCarrier K.P.
        • Atkinson T.M.
        • DeBusk K.P.
        • Liepa A.M.
        • Scanlon M.
        • Coons S.J.
        • Patient-Reported Outcome Consortium N-SCLCWG
        Qualitative development and content validity of the non-small cell lung cancer symptom assessment questionnaire (NSCLC-SAQ), a patient-reported outcome instrument.
        Clin Ther. 2016; 38: 794-810
        • Miller G.A.
        The magical number 7, plus or minus 2 - some limits on our capacity for processing information.
        Psychol Rev. 1956; 63: 81-97
        • Patel K.V.
        • Amtmann D.
        • Jensen M.P.
        • Smith S.M.
        • Veasley C.
        • Turk D.C.
        Clinical outcome assessment in clinical trials of chronic pain treatments.
        Pain Rep. 2021; 6: e784
        • Patrick D.L.
        • Burke L.B.
        • Gwaltney C.J.
        • Leidy N.K.
        • Martin M.L.
        • Molsen E.
        • Ring L.
        Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1–eliciting concepts for a new PRO instrument.
        Value Health. 2011; 14: 967-977
        • Patrick D.L.
        • Burke L.B.
        • Gwaltney C.J.
        • Leidy N.K.
        • Martin M.L.
        • Molsen E.
        • Ring L.
        Content validity–establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: Part 2–assessing respondent understanding.
        Value Health. 2011; 14: 978-988
        • Preston C.C.
        • Colman A.M.
        Optimal number of response categories in rating scales: Reliability, validity, discriminating power, and respondent preferences.
        Acta Psychol (Amst). 2000; 104: 1-15
        • Robinson-Papp J.
        • George M.C.
        • Dorfman D.
        • Simpson D.M.
        Barriers to chronic pain measurement: A qualitative study of patient perspectives.
        Pain Med. 2015; 16: 1256-1264
        • Smith S.M.
        • Amtmann D.
        • Askew R.L.
        • Gewandter J.S.
        • Hunsinger M.
        • Jensen M.P.
        • McDermott M.P.
        • Patel K.V.
        • Williams M.
        • Bacci E.D.
        • Burke L.B.
        • Chambers C.T.
        • Cooper S.A.
        • Cowan P.
        • Desjardins P.
        • Etropolski M.
        • Farrar J.T.
        • Gilron I.
        • Huang I.Z.
        • Katz M.
        • Kerns R.D.
        • Kopecky E.A.
        • Rappaport B.A.
        • Resnick M.
        • Strand V.
        • Vanhove G.F.
        • Veasley C.
        • Versavel M.
        • Wasan A.D.
        • Turk D.C.
        • Dworkin R.H.
        Pain intensity rating training: Results from an exploratory study of the ACTTION PROTECCT system.
        Pain. 2016; 157: 1056-1064
        • Smith S.M.
        • Hunsinger M.
        • McKeown A.
        • Parkhurst M.
        • Allen R.
        • Kopko S.
        • Lu Y.
        • Wilson H.D.
        • Burke L.B.
        • Desjardins P.
        • McDermott M.P.
        • Rappaport B.A.
        • Turk D.C.
        • Dworkin R.H.
        Quality of pain intensity assessment reporting: ACTTION systematic review and recommendations.
        J Pain. 2015; 16: 299-305
        • Treister R.
        • Eaton T.A.
        • Trudeau J.J.
        • Elder H.
        • Katz N.P.
        Development and preliminary validation of the focused analgesia selection test to identify accurate pain reporters.
        J Pain Res. 2017; 10: 319-326
        • Treister R.
        • Lawal O.D.
        • Shecter J.D.
        • Khurana N.
        • Bothmer J.
        • Field M.
        • Harte S.E.
        • Kruger G.H.
        • Katz N.P.
        Accurate pain reporting training diminishes the placebo response: Results from a randomized, double-blind, crossover trial.
        PLoS One. 2018; 13e0197844
      2. U.S. Food & Drug Administration: Patient-Focused Drug Development Guidance Public Workshop: Methods to Identify What is Important to Patients and Select, Develop or Modify Fit-for-Purpose Clinical Outcome Assessments, Center for Drug Evaluation and Research, Silver Spring, MD, 2018

      3. U.S. Food & Drug Administration: Patient-Focused Drug Development Guidance Public Workshop: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making, Center for Drug Evaluation and Research, Silver Spring, MD, 2019

      4. U.S. Food & Drug Administration: Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, Center for Drug Evaluation and Research/Center for Biologics Evaluation and Research, 2020

      5. U.S. Food & Drug Administration: Patient Focused Drug Development: Collecting Comprehensive and Representative Input: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders, Center for Drug Evaluation and Research, Silver Spring, MD, 2020

      6. U.S. Food & Drug Administration: Qualification Process for Drug Development Tools: Guidance for Industry and FDA Staff, Center for Drug Evaluation and Research, Silver Spring, MD, 2020

      7. U.S. Food & Drug Administration: Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders, Center for Drug Evaluation and Research, Silver Spring, MD, 2022