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Responsiveness to Change and Minimally Important Differences of the Patient-Reported Outcomes Measurement Information System Gastrointestinal Symptoms Scales

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Abstract

Background

The NIH-sponsored Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal (GI) Symptoms scales were developed to assess patients’ GI symptoms in clinical settings.

Aims

To assess responsiveness to change and provide minimally important difference (MID) estimates for the PROMIS GI Symptoms scales.

Methods

A sample of 256 GI outpatients self-administered the eight PROMIS GI Symptoms scales (gastroesophageal reflux, disrupted swallowing, diarrhea, bowel incontinence/soilage, nausea and vomiting, constipation, belly pain, and gas/bloating/flatulence) at two visits. Patient self-reported and physician-reported assessments of the subjects’ overall GI condition were employed as change anchors. In addition, we prospectively assessed change at both visits using a GI-symptom anchor, the Gastrointestinal Symptom Rating Scale (GSRS). Responsiveness to change was assessed using F-statistics. The minimally changed group was those somewhat better or somewhat worse on the retrospective anchors and changing by one category on the modified GSRS (e.g., from slight to mild discomfort to moderate to moderately severe discomfort).

Results

Responsiveness to change was statistically significant for 6 of 8 PROMIS scales using the self-report GI anchor, 3 of 8 scales using the physician-reported anchor, and 5 of 5 scales using the corresponding GSRS scales as anchors. The MID estimates for scales for improvement and worsening were about 0.5–0.6 SD using the GSRS anchor and generally larger in magnitude than the change for the “about the same” group.

Conclusions

The responsiveness and MID estimates provided here for the PROMIS GI Symptoms scales can aid in scale score interpretation in clinical trials and observational studies.

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References

  1. Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part I: overall and upper gastrointestinal diseases. Gastroenterology. 2009;136:376–386.

    Article  PubMed  Google Scholar 

  2. Lackner JM, Quigley BM, Blanchard EB. Depression and abdominal pain in IBS patients: the mediating role of catastrophizing. Psychosom Med. 2004;66:435–441.

    PubMed  Google Scholar 

  3. Seres G, Kovacs Z, Kovacs A, et al. Different associations of health related quality of life with pain, psychological distress and coping strategies in patients with irritable bowel syndrome and inflammatory bowel disorder. J Clin Psychol Med Settings. 2008;15:287–295.

    Article  PubMed  Google Scholar 

  4. Spiegel B, Strickland A, Naliboff BD, Mayer EA, Chang L. Predictors of patient-assessed illness severity in irritable bowel syndrome. Am J Gastroenterol. 2008;103:2536–2543.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Khanna P, Agarwal N, Khanna D, et al. Development of an online library of patient-reported outcome measures in gastroenterology: the GI-PRO database. Am J Gastroenterol. 2014;109:234–248.

    Article  PubMed  Google Scholar 

  6. Spiegel BM, Hays RD, Bolus R, et al. Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) gastrointestinal symptom scales. Am J Gastroenterol. 2014;109:1804–1814.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Cella D, Yount S, Rothrock N, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007;45:S3–S11.

    Article  PubMed  PubMed Central  Google Scholar 

  8. De Walt DA, Rothrock N, Yount S, Stone AA, Group PC. Evaluation of item candidates: the PROMIS qualitative item review. Med Care. 2007;45:S12–S21.

    Article  Google Scholar 

  9. Samejima F. Estimation of Latent Ability Using a Response Pattern of Graded Scores (Psychometric Monograph No. 17). Richmond, VA: Psychometric Society. Retrieved from: http://www.psychometrika.org/journal/online/MN17.pdf. 1969.

  10. Khanna D, Furst DE, Maranian P, et al. Minimally important differences of the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument. J Rheumatol. 2011;38:1920–1924.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Glia A, Lindberg G. Quality of life in patients with different types of functional constipation. Scand J Gastroenterol. 1997;32:1083–1089.

    Article  CAS  PubMed  Google Scholar 

  12. Revicki DA, Wood M, Wiklund I, Crawley J. Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease. Qual Life Res. 1998;7:75–83.

    Article  CAS  PubMed  Google Scholar 

  13. Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the Patient-Reported Outcomes Measurement Information System (PROMIS) global items. Qual Life Res. 2009;18:873–880.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33:337–343.

    Article  CAS  PubMed  Google Scholar 

  15. Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008;61:102–109.

    Article  PubMed  Google Scholar 

  16. Hays RD, Farivar SS, Liu H. Approaches and recommendations for estimating minimally important differences for health-related quality of life measures. COPD. 2005;2:63–67.

    Article  PubMed  Google Scholar 

  17. Hays RD, Hadorn D. Responsiveness to change: an aspect of validity, not a separate dimension. Qual Life Res. 1992;1:73–75.

    Article  CAS  PubMed  Google Scholar 

  18. Fries JF, Krishnan E, Bruce B. Items, instruments, crosswalks, and PROMIS. J Rheumatol. 2009;36:1093–1095.

    Article  PubMed  Google Scholar 

  19. Yost KJ, Eton DT, Garcia SF, Cella D. Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients. J Clin Epidemiol. 2011;64:507–516.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol. 2003;56:395–407.

    Article  PubMed  Google Scholar 

  21. Khanna D, Pope JE, Khanna PP, et al. The minimally important difference for the fatigue visual analog scale in patients with rheumatoid arthritis followed in an academic clinical practice. J Rheumatol. 2008;35:2339–2343.

    Article  PubMed  PubMed Central  Google Scholar 

Download references

Acknowledgments

The study was funded by NIH/NIAMS U01 AR057936A, the National Institutes of Health through the NIH Roadmap for Medical Research Grant (AR052177). Dinesh Khanna was also supported by NIAMS K24 AR063120. Puja Khanna was supported by Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant NIAMS 1 T32 AR053463 and ACR Research and Education Foundation Clinical Investigator Fellowship Award 2009_11. Ron D. Hays was also supported by Grants from the National Institute on Aging (P30-AG028748 and P30-AG021684) and the National Cancer Institute (1U2-CCA186878-01). Lin Chang was also supported by NIDDK P50 DK64539.

Financial Disclosures

Dinesh Khanna has served as consultant and/or received Grant support from Actelion, Astra-Zeneca, Bayer, BMS, Corbus, Genentech/Roche, Gilead, GSK, and Sanofi Aventis. Ron D. Hays has served as a consultant to Amgen, Allergan, Pfizer, and the Critical Path Institute. Gil Melmed has served as a consultant for Abbvie, Celgene, Given Imaging, Luitpold Pharmaceuticals, and Jannsen, and has received research support from Pfizer. Lin Chang has served as a consultant to Ironwood, Forest, Prometheus, Salix, Takeda North America, and has received Grant support from Tioga, Salix and Ironwood. Brennan Spiegel has received Grant support from Ironwood, Amgen, Shire Pharmaceuticals, and Theravance Pharmaceuticals, and served as a consultant to Ironwood, Forest, and Takeda North America.

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Authors and Affiliations

  1. Division of Rheumatology, University of Michigan, 1500 E. Medical Center Dr., SPC 5370, Ann Arbor, MI, 48109, USA

    Dinesh Khanna & Puja P. Khanna

  2. Division of General Internal Medicine & Health Services Research, David Geffen School of Medicine at UCLA, 911 Broxton Avenue, Los Angeles, CA, 90024, USA

    Ron D. Hays, Sylvia H. Paz, Tonya Hays & Brennan Spiegel

  3. Department of Health Policy and Management, UCLA Fielding School of Public Health, 911 Broxton Avenue, Los Angeles, CA, 90024, USA

    Ron D. Hays, Sylvia H. Paz, Tonya Hays & Brennan Spiegel

  4. Division of Gastroenterology, University of Michigan, 1500 E. Medical Center Dr., SPC 5362, Ann Arbor, MI, 48109-5362, USA

    Andrew B. Shreiner

  5. Department of Gastroenterology, Cedars-Sinai Medical Center, 8730 Alden Dr., Los Angeles, CA, 90048, USA

    Gil Y. Melmed

  6. Vatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA

    Lin Chang

  7. G. Oppenheimer Family Center for Neurobiology of Stress and Resilience, David Geffen School of Medicine at UCLA, 100 UCLA Medical Plaza, Los Angeles, CA, 90095, USA

    Lin Chang

  8. Department of Gastroenterology, VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd., Los Angeles, CA, 90073, USA

    Roger Bolus & Brennan Spiegel

  9. UCLA/VA Center for Outcomes Research and Education (CORE), 11301 Wilshire Blvd., Los Angeles, CA, 90073, USA

    Roger Bolus, Cynthia Whitman & Brennan Spiegel

  10. UCLA Department of Psychology, 3857 Franz Hall, Los Angeles, CA, 90095, USA

    Steven P. Reise

  11. Division of Rheumatology/Department of Internal Medicine, University of Michigan Scleroderma Program, 300 North Ingalls Street, Suite 7C27, Ann Arbor, MI, 48109, USA

    Dinesh Khanna

  12. Medicine and Public Health, Division of Health Services Research, Cedars-Sinai Health System, Cedars-Sinai and UCLA, 8723 W. Alden Drive, Steven Spielberg Building, Los Angeles, CA, 90048, USA

    Brennan Spiegel

Authors
  1. Dinesh Khanna
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  2. Ron D. Hays
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  3. Andrew B. Shreiner
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  4. Gil Y. Melmed
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  5. Lin Chang
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  6. Puja P. Khanna
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  7. Roger Bolus
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  8. Cynthia Whitman
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  9. Sylvia H. Paz
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  10. Tonya Hays
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  11. Steven P. Reise
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  12. Brennan Spiegel
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Corresponding authors

Correspondence to Dinesh Khanna or Brennan Spiegel.

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All authors declares that they have no conflict of interest to the current research.

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Khanna, D., Hays, R.D., Shreiner, A.B. et al. Responsiveness to Change and Minimally Important Differences of the Patient-Reported Outcomes Measurement Information System Gastrointestinal Symptoms Scales. Dig Dis Sci 62, 1186–1192 (2017). https://doi.org/10.1007/s10620-017-4499-9

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  • DOI: https://doi.org/10.1007/s10620-017-4499-9

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