Metrics Used to Quantify Fecal Incontinence and Constipation

Abstract

While fecal incontinence and constipation can be measured through physiological testing, the subjective experience of severity and impact on health-related quality of life lead to both being most effectively captured through patient-reported measures. Patient-reported measures of severity and impact help to determine baseline symptoms, guide clinical decision making, and compare various treatments. Here, we take pause to review the psychometric qualities that make effective instruments, and discuss some of the most commonly used instruments along with the reasons behind their use. In addition, we highlight the benefits of a standardized instrument designed to evaluate the major symptoms of patients presenting with pelvic floor disorders (including fecal incontinence and constipation). Ultimately, we aim to provide guidance in choosing appropriate instruments for clinical and research use.

Keywords

patient-reported outcomes - fecal incontinence metrics - constipation metrics - severity measures

^* First co-authors.

Publikationsverlauf

Artikel online veröffentlicht:
28. Januar 2021

• References

• 1 McLeod LD, Coon CD, Martin SA, Fehnel SE, Hays RD. Interpreting patient-reported outcome results: US FDA guidance and emerging methods. Expert Rev Pharmacoecon Outcomes Res 2011; 11 (02) 163-169
• 2 U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes 2006; 4: 79
• 3 Baxter NN, Rothenberger DA, Lowry AC. Measuring fecal incontinence. Dis Colon Rectum 2003; 46 (12) 1591-1605
• 4 Karoui S, Savoye-Collet C, Koning E, Leroi AM, Denis P. Prevalence of anal sphincter defects revealed by sonography in 335 incontinent patients and 115 continent patients. AJR Am J Roentgenol 1999; 173 (02) 389-392
• 5 Rasmussen OO, Sørensen M, Tetzschner T, Christiansen J. Dynamic anal manometry in the assessment of patients with obstructed defecation. Dis Colon Rectum 1993; 36 (10) 901-907
• 6 Lacy BE, Mearin F, Chang L. et al. Bowel disorders. Gastroenterology 2016; 150 (06) 1393-1407
• 7 Lee JT, Madoff RD, Rockwood TH. Quality-of-life measures in fecal incontinence: is validation valid?. Dis Colon Rectum 2015; 58 (03) 352-357
• 8 McCrea GL, Miaskowski C, Stotts NA, Macera L, Hart SA, Varma MG. Review article: self-report measures to evaluate constipation. Aliment Pharmacol Ther 2008; 27 (08) 638-648
• 9 Wang JY, Varma MG. Measures for fecal incontinence, constipation, and associated quality of life. Semin Colon Rectal Surg 2010; 21 (01) 22-26
• 10 Rao SSC, Bharucha AE, Chiarioni G. et al. Anorectal disorders. Gastroenterology 2016; 150 (06) 1430-1442
• 11 Van Koughnett JA, Boutros M, Wexner SD. Signs and symptoms in coloproctology: data collection and scores. In: Ratto C, Parello A, Donisi L, Litta F. eds. Colon, Rectum and Anus: Anatomic, Physiologic and Diagnostic Bases for Disease Management. Switzerland: Springer, Cham; 2017: 127-150
• 12 Williams NS, Patel J, George BD, Hallan RI, Watkins ES. Development of an electrically stimulated neoanal sphincter. Lancet 1991; 338 (8776): 1166-1169
• 13 Malouf AJ, Norton CS, Engel AF, Nicholls RJ, Kamm MA. Long-term results of overlapping anterior anal-sphincter repair for obstetric trauma. Lancet 2000; 355 (9200): 260-265
• 14 Reilly WT, Talley NJ, Pemberton JH, Zinsmeister AR. Validation of a questionnaire to assess fecal incontinence and associated risk factors: Fecal Incontinence Questionnaire. Dis Colon Rectum 2000; 43 (02) 146-153 , discussion 153–154
• 15 Chaliha C, Stanton SL. The ethnic cultural and social aspects of incontinence--a pilot study. Int Urogynecol J Pelvic Floor Dysfunct 1999; 10 (03) 166-170
• 16 Bordeianou L, Rockwood T, Baxter N, Lowry A, Mellgren A, Parker S. Does incontinence severity correlate with quality of life? Prospective analysis of 502 consecutive patients. Colorectal Dis 2008; 10 (03) 273-279
• 17 Rockwood TH, Church JM, Fleshman JW. et al. Fecal incontinence quality of life scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum 2000; 43 (01) 9-16 , discussion 16–17
• 18 Rockwood TH, Church JM, Fleshman JW. et al. Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence: the fecal incontinence severity index. Dis Colon Rectum 1999; 42 (12) 1525-1532
• 19 Ware Jr JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 30 (06) 473-483
• 20 Rockwood TH. Incontinence severity and QOL scales for fecal incontinence. Gastroenterology 2004; 126 (01) (Suppl. 01) S106-S113
• 21 Rothbarth J, Bemelman WA, Meijerink WJ. et al. What is the impact of fecal incontinence on quality of life?. Dis Colon Rectum 2001; 44 (01) 67-71
• 22 Eypasch E, Williams JI, Wood-Dauphinee S. et al. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg 1995; 82 (02) 216-222
• 23 Wiesel PH, Norton C, Roy AJ, Storrie JB, Bowers J, Kamm MA. Gut focused behavioural treatment (biofeedback) for constipation and faecal incontinence in multiple sclerosis. J Neurol Neurosurg Psychiatry 2000; 69 (02) 240-243
• 24 Streiner DL, Norman GR. . Health Measurement Scales. A Practical Guide to Their Development and Use. Oxford: Oxford University Press; 1994: 104-127
• 25 Nunnally JC, Bernstein IH. Psychometric Theory. New York: McGraw Hill; 1994: 248-292
• 26 Izumi K. The measures to evaluate constipation: a review article. Gastroenterol Nurs 2014; 37 (02) 137-146
• 27 Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum 1993; 36 (01) 77-97
• 28 Pescatori M, Anastasio G, Bottini C, Mentasti A. New grading and scoring for anal incontinence. Evaluation of 335 patients. Dis Colon Rectum 1992; 35 (05) 482-487
• 29 Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut 1999; 44 (01) 77-80
• 30 Norton NJ. The perspective of the patient. Gastroenterology 2004; 126 (01) (Suppl. 01) S175-S179
• 31 Brown HW, Wexner SD, Lukacz ES. Factors associated with care seeking among women with accidental bowel leakage. Female Pelvic Med Reconstr Surg 2013; 19 (02) 66-71
• 32 Hussain ZI, Lim M, Stojkovic S. The test-retest reliability of fecal incontinence severity and quality-of-life assessment tools. Dis Colon Rectum 2014; 57 (05) 638-644
• 33 Bug GJ, Kiff ES, Hosker G. A new condition-specific health-related quality of life questionnaire for the assessment of women with anal incontinence. BJOG 2001; 108 (10) 1057-1067
• 34 Wexner SD, Baeten C, Bailey R. et al. Long-term efficacy of dynamic graciloplasty for fecal incontinence. Dis Colon Rectum 2002; 45 (06) 809-818
• 35 Kelleher CJ, Cardozo LD, Khullar V, Salvatore S. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol 1997; 104 (12) 1374-1379
• 36 Agachan F, Chen T, Pfeifer J, Reissman P, Wexner SD. A constipation scoring system to simplify evaluation and management of constipated patients. Dis Colon Rectum 1996; 39 (06) 681-685
• 37 Frank L, Kleinman L, Farup C, Taylor L, Miner Jr P. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol 1999; 34 (09) 870-877
• 38 McMillan SC, Williams FA. Validity and reliability of the Constipation Assessment Scale. Cancer Nurs 1989; 12 (03) 183-188
• 39 Varma MG, Wang JY, Berian JR, Patterson TR, McCrea GL, Hart SL. The constipation severity instrument: a validated measure. Dis Colon Rectum 2008; 51 (02) 162-172
• 40 Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol 2005; 40 (05) 540-551
• 41 Wang JY, Hart SL, Lee J, Berian JR, McCrea GL, Varma MG. A valid and reliable measure of constipation-related quality of life. Dis Colon Rectum 2009; 52 (08) 1434-1442
• 42 Bharucha AE, Locke III GR, Seide BM, Zinsmeister AR. A new questionnaire for constipation and faecal incontinence. Aliment Pharmacol Ther 2004; 20 (03) 355-364
• 43 Osterberg A, Graf W, Karlbom U, Påhlman L. Evaluation of a questionnaire in the assessment of patients with faecal incontinence and constipation. Scand J Gastroenterol 1996; 31 (06) 575-580
• 44 Heaton KW, O'Donnell LJ. An office guide to whole-gut transit time. Patients' recollection of their stool form. J Clin Gastroenterol 1994; 19 (01) 28-30
• 45 Bordeianou LG, Anger JT, Boutros M. et al; MEMBERS OF THE PELVIC FLOOR DISORDERS CONSORTIUM WORKING GROUPS ON PATIENT-REPORTED OUTCOMES. Measuring Pelvic Floor Disorder Symptoms Using Patient-Reported Instruments: Proceedings of the Consensus Meeting of the Pelvic Floor Consortium of the American Society of Colon and Rectal Surgeons, the International Continence Society, the American Urogynecologic Society, and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction. Dis Colon Rectum 2020; 63 (01) 6-23
• 46 Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol 2001; 185 (06) 1388-1395