Table 5.
Reporting of outcome domains in the 47 included studies according to the OMERACT 2.0 filter core area “pathophysiological manifestations”
| Outcome (sub)domain |
Outcome reporting in (sub)domains n studies (%) |
Outcomes reported within domain | Measurement instruments |
|---|---|---|---|
| Defecation functions23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 49, 50, 51, 52, 53, 54, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69 | 44 (94) | ||
| Defecation frequency19, 21, 22, 23, 24, 25, 27, 28, 29, 31, 32, 33, 34, 35, 36, 37, 38, 39, 41, 42, 43, 45, 46, 48, 49, 50, 52, 53, 54, 55, 56, 57, 58, 59, 60, 62, 63, 64, 65 | 39 (83) |
• Defecation frequency • Defecation frequency associated with complete evacuation |
• Patient diary • Telephone interview • Undefined questionnaire(s) |
| General defecation functions28, 31, 32, 33, 40, 41, 42, 46, 48, 49, 50, 51, 54, 55, 57, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69 | 25 (53) |
• Constipation symptoms (general) • Constipation severity |
• VAS • KESS score • Rome III criteria • SCL‐90 • CAS • PAC‐SYM • Wexner constipation score • Agachan score • CCSS • Patient diary • Undefined questionnaire(s) |
| Elimination of feces25, 26, 27, 29, 32, 33, 38, 41, 43, 47, 52, 57, 58, 59, 63, 64, 65 | 17 (36) |
• Straining • Incomplete evacuation • Need to digitate/assisted defecation • Difficulty with rectal evacuation • Anorectal motility |
• 5‐point Likert scale • Anorectal manometry • Balloon expulsion test • Stationary pull through • Patient diary • Undefined questionnaire(s) |
| Fecal consistency23, 26, 35, 38, 39, 41, 47, 52, 57, 58, 59, 60, 64, 66, 67, 68 | 16 (34) | • Stool consistency |
• Bristol stool scale • Patient diary • (Telephone) interview • Undefined questionnaire(s) |
| Fecal continence34, 39, 42, 50, 51, 52, 58, 59, 62, 63 | 10 (21) |
• Anal/fecal incontinence • Soiling |
• Holschneider score • Telephone interview • Wexner incontinence score • Vaizey incontinence score • Patient diary • Undefined questionnaire(s) |
| Other23, 26, 32, 43, 53, 63 | 6 (13) |
• Stool weight • Time spent toileting |
• Patient diary • Scale |
| Flatulence23, 64 | 2 (4) | • Flatulence |
• Interview • Patient diary • 5‐point Likert scale |
| Digestive functions23, 24, 25, 26, 27, 28, 29, 30, 33, 35, 36, 37, 40, 41, 44, 45, 47, 49, 53, 56, 64, 65, 66, 67, 68 | 25 (53) |
• Colonic/whole‐gut transit time • Mouth‐to‐cecum transit time • Gastrointestinal transit time • Geometric center • Colonic motility • Gastric emptying |
• Radiopaque marker study • Scintigraphic study • Hydrogen breath test • Manometry • Undefined questionnaire(s) |
| Sensation of pain19, 21, 22, 23, 28, 29, 30, 35, 37, 38, 43, 46, 48, 49, 52, 53, 54, 55, 56, 58, 60, 62, 65 | 23 (49) |
• Pain (general) • Abdominal pain • Pelvic and anorectal pain • Abdominal, pelvic, and anorectal pain |
• VAS • GIQLI • Patient diary • (Telephone) interview • Undefined questionnaire(s) |
| Sensations associated with digestive system23, 27, 32, 33, 41, 42, 45, 47, 56, 57, 59, 60, 62, 64, 66 | 15 (32) |
• Nausea • Abdominal bloating/fullness • Borborygmi • Urgency • Pyrosis • Belching |
• GIQLI • Interview • Patient diary • Undefined questionnaire(s) |
| Blood26, 62 | 2 (4) | • Blood levels | • Not clear |
| Ingestion functions45, 62 | 2 (4) | • Vomiting | • Undefined questionnaire(s) |
| Weight maintenance functions23 | 1 (2) | • Anorexia | • Interview |
| Urinary functions63 | 1 (2) | • Urinary complaints | • Patient diary |
CAS, Constipation Assessment Scale; CCSS, Cleveland Clinic Constipation Score System; GIQLI, Gastrointestinal Quality of Life Index; KESS, Knowles Eccersley Scott Symptom; PAC‐SYM, Patient Assessment of Constipation Symptoms; SCL‐90, Symptom Checklist 90; VAS, Visual Analogue Scale.