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Pain Measurement in Children with Functional Abdominal Pain

  • Pediatric Gastroenterology (SR Orenstein, Section Editor)
  • Published:
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Abstract

Functional abdominal pain (FAP) occurs frequently in pediatric patients. Lacking clear biomarkers, clinicians and researchers must rely on patient reports of pain intensity. Presently, there are challenges affecting our ability to use existing measures of self-reported pediatric pain intensity. This report discusses those challenges, finding that: (a) inter-rater agreement of children’s pain intensity is generally low; (b) typically used approaches to measuring outcomes may yield high levels of unreliable reports of improvement; (c) a distribution-based approach involving the calculation of a reliable change index can produce results that classify individuals as improved reliably, but this approach needs to be combined with another approach that ensures the findings will be clinically meaningful as well; (d) clinical trials for FAP rarely report findings about how many individuals improve in a statistically reliable, clinically meaningful manner; and (e) more information about the test–retest reliability of commonly used measures is needed to accurately gauge treatment-related improvement.

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Notes

  1. the formula for the RCI is

    $$ \mathrm{R}\mathrm{C}\mathrm{I}=\frac{{\mathrm{M}}_{\mathrm{post}\hbox{-} \mathrm{test}}-{\mathrm{M}}_{\mathrm{pre}\hbox{-} \mathrm{test}}}{\mathrm{Standard}\;\mathrm{error}\;\mathrm{of}\;\mathrm{the}\;\mathrm{difference}\;\mathrm{between}\;\mathrm{means}} $$

    The formula for the standard error of the difference between means includes the test–retest reliability of the measure (Pearson correlation).

Abbreviations

CSC:

Clinically significant change

EMA:

European Medicines Agency

FAP:

Functional abdominal pain

FDA:

U.S. Food and Drug Administration

FGID:

Functional gastrointestinal disorder

IBS:

Irritable bowel syndrome

IMMPACT:

Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials

MCID:

Minimal clinically important difference

NNT:

Number needed to treat

NRS:

Numeric rating scale

PRO:

Patient-reported outcome

RCI:

Reliable change index

RCT:

Randomized controlled trial

SD:

Standard deviation

SEM:

Standard error of the mean

VAS:

Visual analogue scale

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Author information

Authors and Affiliations

  1. Department of Child and Adolescent Psychiatry, Ann & Robert H. Lurie Children’s Hospital of Chicago, 225 E Chicago Ave, Chicago, 60611, IL, USA

    John V. Lavigne

  2. Feinberg School of Medicine, Northwestern University, Evanston, IL, USA

    John V. Lavigne

  3. Mary Ann and J. Milburn Smith Child Health Research Program, Chicago, IL, USA

    John V. Lavigne

  4. Children’s Hospital of Chicago Research Center, Chicago, IL, USA

    John V. Lavigne

  5. Division of Pediatric Gastroenterology, Hepatology and Nutrition, Research Center for the Investigation of Functional and Gastrointestinal Motility Disorders in Children, Nationwide Children’s Hospital, 700 Children’s Drive, Columbus, 43205, OH, USA

    Miguel Saps

  6. College of Medicine, Ohio State University, Columbus, OH, USA

    Miguel Saps

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Correspondence to Miguel Saps.

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Conflict of Interest

John V. Lavigne declares that he has no conflicts of interest. Miguel Saps reports consultancy for Ardelyx, Nutricia, Quintiles, QOL Medical, Forest, IM Health Science, and Shire outside the submitted work.

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This article does not contain any studies with human or animal subjects performed by any of the authors.

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This article is part of the Topical Collection on Pediatric Gastroenterology

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Lavigne, J.V., Saps, M. Pain Measurement in Children with Functional Abdominal Pain. Curr Gastroenterol Rep 18, 20 (2016). https://doi.org/10.1007/s11894-016-0493-1

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