Skip to main content
SpringerLink
Log in

Methodologies of PD Assessment: Scales

  • Living reference work entry
  • First Online:
Drug Discovery and Evaluation: Methods in Clinical Pharmacology

  • 461 Accesses

Abstract

Scales and behavioral tests are the primary source of data in human research for measuring, modeling, and testing perception, thoughts, feelings, complains, and performance. In drug development scales and tests are used in clinical trials as tools to support diagnosis; evaluate states and traits, as well as lifestyle and performance of patients; or collect ratings by relatives and health carers before, during, and after treatment. Clinical scales can be classified according to several criteria; one classification is according to the intended responder and the method of data generation (FDA 2016; Walton et al. Value Health 18:741–752, 2015). Well-developed and ready-for-purpose scales and tests can be used to describe, characterize, or quantify (localize) objects and processes within a framework of a pharmacological clinical study or preferably of a drug development program of interest. In the present article the conceptualization, development, selection, analysis, and application of items and scales in various phases of clinical drug development are presented in an overview and discussed.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution

Institutional subscriptions

References and Further Reading

  • Acquadro C, Jambon B, Ellis D, Marquis P (1996) Language and translation issues. In: Spilker B (ed) Quality of life and pharmacoeconomics in clinical trials. Lippincott-Raven, Philadelphia, pp 575–585

    Google Scholar 

  • Agresti A (1996) An introduction to categorical data analysis. Wiley, New York

    Google Scholar 

  • AMDP&CIPS (1990) Rating scales for psychiatry, European edn. Beltz Test GmbH, Weinheim

    Google Scholar 

  • APA (American Psychiatric Association) (2013) Diagnostic and statistical manual of mental disorders: DSM-5, 5th edn. American Psychiatric Association, Washington, DC

    Google Scholar 

  • APA (American Psychological Association) (2014) Standards for educational and psychological testing. American Educational Research Association, Washington, DC. http://www.apa.org/science/programs/testing/standards.aspx

    Google Scholar 

  • Asadi-Lari M, Tamburini M, Gray D (2004) Patients’ needs, satisfaction, and health related quality of life: towards a comprehensive model. Health Qual Life Outcomes 2:32

    Article  PubMed  PubMed Central  Google Scholar 

  • Biel V. Big data analytics. http://www.webopedia.com/TERM/B/big_data_analytics.html

  • Bland JM, Altman DG (1996) Measurement error and correlation coefficients. Br J Med 313:41–42

    Article  CAS  Google Scholar 

  • Borg I, Groenen P (2005) Modern multidimensional scaling: theory and applications, 2nd edn. Springer, New York. 2nd edn. Washington, DC: American Council on Education

    Google Scholar 

  • Cohen J (1960) A coefficient of agreement for nominal scales. Educ Psychol Meas 20(1):37–46

    Article  Google Scholar 

  • Cohen J (1968) Weighted kappa: nominal scale agreement with provision for scaled disagreement or partial credit. Psychol Bull 70:213–220

    Article  CAS  PubMed  Google Scholar 

  • Cohen J (1977) Statistical power analysis for the behavioural sciences, revth edn. Academic, New York

    Google Scholar 

  • Committee for Medicinal Products for Human Use (2005) Reflection paper on the regulatory guidance for the use of Health-Related Quality of Life (HRQL) measures in the evaluation of medicinal products. EMEA, London

    Google Scholar 

  • Cronbach LJ (1971) Test validation. In: Thorndike RL (ed) Educational measurement. American Council on Education, Washington, DC, pp 443–507

    Google Scholar 

  • Cronbach LJ (2004) My current thoughts on coefficient alpha and successor procedures. Educ Psychol Meas 64:391–418

    Article  Google Scholar 

  • Cronbach LJ, Meehl PE (1955) Construct validity in psychological tests. Psychol Bull 52:281–302

    Article  CAS  PubMed  Google Scholar 

  • EMEA (2007) Innovative drug development approaches, EMEA/127318/2007. EMEA, London

    Google Scholar 

  • Fleiss JL (1971) Measuring nominal scale agreement among many raters. Psychol Bull 76(5):378–382

    Article  Google Scholar 

  • Fleiss JL (1981) Statistical methods for rates and proportions, 2nd edn. Wiley, New York, pp 38–46

    Google Scholar 

  • Fleiss JL, Cohen J (1973) The equivalence of weighted kappa and the intraclass correlation coefficient as measures of reliability. Educ Psychol Meas 33:613–619

    Article  Google Scholar 

  • Food and Drug Administration (2000) Title 21 Code of Federal Regulations (21 CFR Part 11) Electronic Records; Electronic Signatures. http://www.fda.gov/ora/compliance_ref/Part11/

  • Food and Drug Administration (2006). Guidance for industry, patient-reported outcome measures: use in medical product development to support labeling claims, Silver Spring

    Google Scholar 

  • Food and Drug Administration (2009) Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. Available from: http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf. Accessed 3 Jan 2017

  • Food and Drug Administration (2016) Clinical outcome assessment (COA): glossary of terms. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm370262.htm. Accessed 3 Jan 2017

  • Food and Drug Administration (2017) Clinical outcome assessment qualification program. https://www.fda.gov/drugs/developmentapprovalprocess/drugdevelopmenttoolsqualificationprogram/ucm284077.htm. Page Last Updated: 06 Aug 2017

  • Gartner IT. Glossary. https://research.gartner.com/definition-whatis-big-data?resId=3002918&srcId=1-8163325102

  • Guilford JP (1946) New standards for test evaluation. Educ Psychol Meas 6(5):427–439

    Article  Google Scholar 

  • Hamilton M (1960) A rating scale for depression. J Neurol Neurosurg Psychiatry 23:56–62

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Kahneman D (2011) Thinking, fast and slow. Farrar, Straus and Giroux, New York

    Google Scholar 

  • Kelly P (2015) Electronic questionnaires at statistics Canady. https://wwwn.cdc.gov/qbank/QUest/2015/s423-paul_kelly_quest2015.pdf

  • Kendell R, Jablensky A (2003) Distinguishing between the validity and utility of psychiatric diagnoses. Am J Psychiatry 160(1):4–12

    Article  PubMed  Google Scholar 

  • Kundel HL, Nodine CF, Conant EF, Weinstein SP (2007) Holistic component of image perception in mammogram interpretation: gaze-tracking study. Radiology 242:396–402

    Article  PubMed  Google Scholar 

  • Lienert GA, Raatz V (1998) Testaufbau und Testanalyse. Weinheim, Psychologie Verlags Union 1998 (6. Aufl)

    Google Scholar 

  • Linden WJ, van der Hambleton RK (1997) Handbook of modern item response theory. Springer, New York

    Book  Google Scholar 

  • Little RJA, Rubin DB (1987) Statistical analysis with missing data. Wiley, New York

    Google Scholar 

  • Messick S (1989) Validity. In: Linn R (ed) Educational measurement, 3rd edn. American Council on Education and Macmillan, New York, pp 13–103

    Google Scholar 

  • Middel B, van Sonderen E (2002) Statistical significant change versus relevant or important change in (quasi) experimental design: some conceptual and methodological problems in estimating magnitude of intervention-related change in health services research. Int J Integ Care 2.:2002:e15

    Google Scholar 

  • NASA Report. ftp://ftp.hq.nasa.gov/pub/pao/reports/1999/MCO_report.pdf

  • National Institute of Mental Health. Research priorities. NIMH page on RDoC. http://www.nimh.nih.gov/research-priorities/rdoc/index.shtml

  • Obuchowski NA (2005) ROC analysis. Am J Roentgenol 184:364–372

    Article  Google Scholar 

  • Osgood CE, Suci G, Tannenbaum P (1957) The measurement of meaning. University of Illinois Press, Urbana

    Google Scholar 

  • Patrick DL et al (2007) Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health 10(Supplement 2):S125–S137

    Article  PubMed  Google Scholar 

  • Powers JH, Patrick DL, Walton MK, Marquis P, Cano S, Hobart J, Isaac M, Vamvakas S, Slagle A, Molsen E, Burke LB (2017) Clinician-reported outcome assessments of treatment benefit: report of the ISPOR clinical outcome assessment emerging good practices task force. Value Health 20(1):2–14. https://doi.org/10.1016/j.jval.2016.11.005

    Article  PubMed  PubMed Central  Google Scholar 

  • Rasch G (1960) Probabilistic models for some intelligence and achievement tests. Danish Institute for Educational Research (expanded edition), 1980, Copenhagen. University of Chicago Press, Chicago

    Google Scholar 

  • Rost J (2004) Lehrbuch Testtheorie – Testkonstruktion. Huber, Bern (2. Aufl)

    Google Scholar 

  • Schadow G, McDonald CJ (2014) The unified code for units of measure. Regenstrief Institute, Inc. and the UCUM Organization 1988–2014. http://unitsofmeasure.org/ucum.html

  • Schwarz N (1999) Self-reports. How questions shape the answer. Am Psychol 54(2):93–105

    Article  Google Scholar 

  • Stevens SS (1951) Mathematics, measurement and psychophysics. In: Stevens SS (ed) Handbook of experimental psychology. Wiley, New York, pp 1–49

    Google Scholar 

  • Thompson B (ed) (2003) Score reliability: contemporary thinking on reliability issues. Sage, Thousand Oaks

    Google Scholar 

  • Walton MK, Powers JH III, Hobart J et al (2015) Clinical outcome assessments: conceptual foundation: report of the ISPOR clinical outcomes assessment – emerging good practices for outcomes research task force. Value Health 18:741–752

    Article  PubMed  PubMed Central  Google Scholar 

  • WHO. http://www.who.int/classifications/icd/en/

  • Wild D, Eremenco S, Mear I, Martin M, Houchin C, Gawlicki M, Hareendran A, Wiklund I, Chong LY, von Maltzahn R, Cohen L, Molsen E (2009) Multinational trials – recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: the ISPOR patient-reported outcomes translation and linguistic validation good research practices task force report. Value Health 12(4.) 2009):430

    Article  PubMed  Google Scholar 

  • Wilke RJ, Burke LB, Erickson P (2004) Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved labels. Control Clin Trials 25:535–552

    Article  Google Scholar 

  • William HL, Conway MA, Cohen G (2008) Autobiographical memory. In: Cohen G, Conway M (eds) Memory in the real world, 3rd edn. Psychology Press, Hove

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Scientific Consulting, Schwindstraße 4, 60325, Frankfurt am Main, Germany

    Roman Görtelmeyer

  2. Biological and Clinical Psychology, University of Mannheim, L 13,15-17, 68161, Mannheim, Germany

    Roman Görtelmeyer

Authors
  1. Roman Görtelmeyer
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Roman Görtelmeyer .

Editor information

Editors and Affiliations

  1. CorDynamics , Dieburg, Germany

    Franz J. Hock

  2. CorDynamics , Chicago, Illinois, USA

    Michael R. Gralinski

Rights and permissions

Reprints and permissions

Copyright information

© 2017 Springer International Publishing AG

About this entry

Cite this entry

Görtelmeyer, R. (2017). Methodologies of PD Assessment: Scales. In: Hock, F., Gralinski, M. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Cham. https://doi.org/10.1007/978-3-319-56637-5_27-1

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-56637-5_27-1

  • Received:

  • Accepted:

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-56637-5

  • Online ISBN: 978-3-319-56637-5

  • eBook Packages: Springer Reference Biomedicine and Life SciencesReference Module Biomedical and Life Sciences

Publish with us

Policies and ethics

Search

Navigation