Employing irritable bowel syndrome patient-reported outcomes in the clinical trenches

Conclusions

IBS is a common, chronic, relapsing disease that often leads to physical, mental, and social distress. Without objective measurable biomarkers to assess IBS patients’ GI symptom burden, along with health care’s increased emphasis on patient-centered care, it becomes important to accurately capture a patient’s illness experience with PROs. A number of IBS symptom and QOL PRO instruments have been described in the literature, but most are beset by lengthy completion times and are impractical for use in everyday care. GI PROMIS, on the other hand, is a versatile and efficient instrument for collecting PRO data from not only IBS patients, but also all those who seek care in our GI clinics. Improvements in PRO and implementation science combined with technological advances have lessened the barriers to employing PROs in routine clinical care, and an increasing number of institutions are beginning to take up this challenge. In doing so and by seamlessly incorporating PROs in clinical practice, it facilitates placement of our patients’ voices at the forefront of their health care, changes how we monitor and manage patients, and, ultimately, may improve patient satisfaction and clinical outcomes.

Content from this column was originally published in the “Practice Management: The Road Ahead” section of Clinical Gastroenterology and Hepatology (2018;16:462-6).

References

1. Detmar S.B., Muller M.J., Schornagel J.H., et al. Role of health-related quality of life in palliative chemotherapy treatment decisions. J Clin Oncol. 2002;20:1056-62.

2. Detmar S.B., Muller M.J., Schornagel J.H., et al. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002;288:3027-34.

3. Neumann M., Edelhauser F., Kreps G.L., et al. Can patient-provider interaction increase the effectiveness of medical treatment or even substitute it? An exploration on why and how to study the specific effect of the provider. Patient Educ Couns. 2010;80:307-14.

4. Lembo A.J. The clinical and economic burden of irritable bowel syndrome. Pract Gastroenterol. 2007;31:3-9.

5. Valderas J.M., Kotzeva A., Espallargues M., et al. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008;17:179-93.

6. Almario C.V., Chey W.D., Khanna D., et al. Impact of National Institutes of Health gastrointestinal PROMIS measures in clinical practice: results of a multicenter controlled trial. Am J Gastroenterol. 2016;111:1546-56.

7. Basch E., Deal A.M., Kris M.G., et al. Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol. 2016;34:557-65.

8. Kotronoulas G., Kearney N., Maguire R., et al. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol. 2014;32:1480-501.

9. Basch E., Deal A.M., Dueck A.C., et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA. 2017;318:197-8.

10. Spiegel B.M. Patient-reported outcomes in gastroenterology: clinical and research applications. J Neurogastroenterol Motil. 2013;19:137-48.

11. Mangel A.W., Hahn B.A., Heath A.T., et al. Adequate relief as an endpoint in clinical trials in irritable bowel syndrome. J Int Med Res. 1998;26:76-81.

12. Francis C.Y., Morris J., Whorwell P.J. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997;11:395-402.

13. Wiklund I.K., Fullerton S., Hawkey C.J., et al. An irritable bowel syndrome-specific symptom questionnaire: development and validation. Scand J Gastroenterol. 2003;38:947-54.

14. Drossman D.A., Li Z., Toner B.B., et al. Functional bowel disorders. A multicenter comparison of health status and development of illness severity index. Dig Dis Sci. 1995;40:986-95.

15. Roalfe A.K., Roberts L.M., Wilson S. Evaluation of the Birmingham IBS symptom questionnaire. BMC Gastroenterol. 2008;8:30.

16. Patrick D.L., Drossman D.A., Frederick I.O., et al. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998;43:400-11.

17. Hahn B.A., Kirchdoerfer L.J., Fullerton S., et al. Evaluation of a new quality of life questionnaire for patients with irritable bowel syndrome. Aliment Pharmacol Ther. 1997;11:547-52.

18. Shaw M., Talley N.J., Adlis S., et al. Development of a digestive health status instrument: tests of scaling assumptions, structure and reliability in a primary care population. Aliment Pharmacol Ther. 1998;12:1067-78.

19. Chassany O., Marquis P., Scherrer B., et al. Validation of a specific quality of life questionnaire for functional digestive disorders. Gut. 1999;44:527-33.

20. Wong E., Guyatt G.H., Cook D.J., et al. Development of a questionnaire to measure quality of life in patients with irritable bowel syndrome. Eur J Surg Suppl. 1998;583:50-6.

21. Groll D., Vanner S.J., Depew W.T., et al. The IBS-36: a new quality of life measure for irritable bowel syndrome. Am J Gastroenterol. 2002;97:962-71.

22. Lee E.H., Kwon O., Hahm K.B., et al. Irritable bowel syndrome-specific health-related quality of life instrument: development and psychometric evaluation. Health Qual Life Outcomes. 2016;14:22.

23. Spiegel B.M., Hays R.D., Bolus R., et al. Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) gastrointestinal symptom scales. Am J Gastroenterol. 2014;109:1804-14.

24. Bijkerk C.J., de Wit N.J., Muris J.W., et al. Outcome measures in irritable bowel syndrome: comparison of psychometric and methodological characteristics. Am J Gastroenterol. 2003;98:122-7.

25. HealthMeasures. Data collection tools. 2017. Available from https://www.healthmeasures.net/resource-center/data-collection-tools. Accessed August 20, 2017.

26. Baumhauer J.F. Patient-reported outcomes – are they living up to their potential?. N Engl J Med. 2017;377:6-9.