Characteristics of Included Studies
| PROM | Authors | Type of constipation | Participants (validation study) |
Method of administration | Recall period | Items and subsets | Location of study | Original language |
|---|---|---|---|---|---|---|---|---|
| Constipation symptoms | ||||||||
| BF-Diary | Camilleri et al,15 2011 | OIC | 238 patients with chronic pain | Handheld electronic PDA device | Past 24 hours and immediately after each defecation event for some items | 10 items (3 modules per bowel movement, daily assessment, and treatments used) | USA | English |
| BFI | Rentz et al,16 2009 | OIC | 985 patients with chronic pain (202 Phase II; 460 Phase III; 323 Phase III) | Clinician administered | Last 7 days | 3 items | Germany | English |
| Ducrotté and Caussé,17 2012 | OIC | 987 patients with chronic pain (202 Phase II, 463 Phase III, 322 Phase III) | Clinician administered | Last 7 days | 3 items | France | English | |
| Abramowitz et al,18 2013 | OIC | 520 patients with pain induced by cancer | Clinician administered | Last 7 days | 3 items | France | English | |
| Chinese Constipation Questionnaire | Chan et al,19 2005 | Functional constipation | 221 (111 patients with chronic constipation, 110 healthy controls) | Pen and paper | Past 2 weeks | 6 items | Hong Kong | Chinese |
| CC Symptom Severity Measures | Nelson et al,20 2014 | Chronic constipation | 1579 with chronic constipation (307 Phase IIb; 1272 Phase III) | Telephone-based IVRS | Administered daily during trial | 7 items (2 subscales: bowel and abdominal symptoms) | USA | English |
| CAS | McMillan and Williams,21 1989 | Iatrogenic constipation | 64 (32 at risk for constipation, 32 healthy controls) | Pen and paper | Past week | 8 items | USA | English |
| Constipation during pregnancy questionnaire | Ponce et al,22 2008 | Constipation during pregnancy | 207 pregnant women | Pen and paper, telephone interview (follow ups) | None reported | 42 items (5 subscales: demographic, obstetric history, bowel habits and laxative consumption, lifestyle and eating habits, and urinary or fecal incontinence) | Spain | Not reported |
| CSI | Varma et al,23 2008 | Multiple subtypes | 294 (191 patients with constipation, 103 healthy controls) | Pen and paper | Last month (2 items), no recall period (14 items) | 16 items (3 subscales: obstructive defecation, colonic inertia, and pain) | USA | English |
| CSS | Agachan et al,24 1996 | Idiopathic constipation | 232 patients with constipation | Pen and paper | None reported | 8 items | USA | English |
| DIBSS-C | Coon et al,25 2020 | IBS-C | 532 IBS-C patients from multicentre phase IIb study | Handheld electronic diary | Every BM event (3 items), past 24 hours (3 items) | 7 items (2 subcales: bowel movement-related symptoms and abdominal symptoms severity) | USA | English |
| FICA | Bharucha et al,26 2004 | Functional constipation & faecal incontinence | 83 women | Pen and paper | Last 12 months (symptoms-related items) | 98 items (8 subscales: general bowel habits, abdominal pain, treatment of constipation, faecal incontinence, urinary symptoms, anorectal disease, surgical history and other, health care utilization, and quality of life) | USA | English |
| Fecal Incontinence and Constipation Questionnaire | Österberg et al,27 1996 | Constipation & faecal incontinence | 90 (36 with faecal incontinence, 38 with constipation, 16 healthy controls) | Pen and paper | None reported | 38 items | Sweden | Not reported |
| IBS-C Symptom Severity Measures | Williams et al,28 2014 | IBS-C | 1608 patients with IBS-C | Telephone-based IVRS | Administered daily during trial | 9 items (2 subscales: bowel and abdominal symptoms subsets) | USA | English |
| KESS | Knowles et al,29 2000 | Chronic constipation | 91 (71 patients with chronic constipation, 20 healthy controls) | Researcher administered | None reported | 11 items | UK | English |
| ODS-S | Renzi et al,30 2013 | ODS | 200 (100 patients with ODS, 100 healthy controls) | Pen and paper | None reported | 5 items | Italy | Not reported |
| ODS Score | Altomare et al,31 2008 | ODS | 106 (76 patients with ODS, 30 healthy controls) | Researcher administered | None reported | 8 items | Italy | Not reported |
| PAC-SYM | Frank et al,32 1999 | Chronic constipation | 216 patients with chronic constipation | Pen and paper | Past 2 weeks | 12 items (3 subscales: stool, rectal, and abdominal symptoms) | USA | English |
| Modified PAC-SYM | Neri et al,33 2015 | Chronic constipation | 2203 patients with chronic constipation | Pen and paper | Past 2 weeks | 11 items (2 subscales: stool and abdominal symptoms) | Italy | English |
| Rome III Criteria Questionnaire | Digesu et al,34 2010 | Functional constipation (Rome III) | 201 women | Pen and paper | Last 3 months (9 items), last 6 months (2 items), no recall period (6 items) | 17 items | UK | English |
| VSAQ | Pamuk et al,35 2003 | Constipation (unspecified) | 369 hospital personnel | Pen and paper | Last 12 months (symptoms-related items) | 5 items | Turkey | Not reported |
| Constipation-related quality of life | ||||||||
| CTSAT-Q | Szeinbach et al,36 2009 | Chronic constipation and IBS-C | 311 patients with chronic constipation and IBS-C | Online questionnaire | None reported | 12 items (5 subscales: expectations, value, treatment satisfaction, activities, and effectiveness) | USA | English |
| Constipation-related Disability Scale | Hart et al,37 2012 | Chronic constipation | 343 (240 patients with constipation, 103 healthy controls) | Pen and paper | Past week | 13 items (2 subscales: leisure/work activities and activities of daily living) | USA | English |
| CRQOL | Wang et al,38 2009 | Chronic constipation | 343 (240 patients with constipation, 103 healthy controls) | Pen and paper | Past 12 months | 18 items (4 subscales: social impairment, distress, eating habits, and bathroom attitudes) | USA | English |
| E-CIS | Abdul Wahab et al,39 2020 | Chronic constipation | 470 elderly people with chronic constipation | Researcher administered | None reported | 22 items (7 subscales: daily activities, treatment satisfaction, lack of control of bodily function, diet restriction, symptom intensity, anxiety, and preventive actions) | Malaysia | Malay |
| PAC-QOL | Marquis et al,40 2005 | Chronic constipation | 223 patients with chronic constipation | Pen and paper | Past 2 weeks | 28 items (4 subscales: worries/concerns, physical discomfort, psychosocial discomfort, and satisfaction) | USA, UK, France, Sweden | English |
PROM, patient-reported outcome measure; BF-Diary, Bowel Function Diary; BFI, Bowel Function Index; CC, chronic constipation; CAS, Constipation Assessment Scale; CSI, Constipation Severity Instrument; CSS, Constipation Scoring System; DIBSS-C, Diary for Irritable Bowel Syndrome Symptoms–Constipation; FICA, Fecal Incontinence and Constipation Assessment; IBS-C, constipation-predominant irritable bowel syndrome; KESS, Knowles-Eccersley-Scott Symptom Questionnaire; ODS-S, Obstructive Defecation Syndrome Score; PAC-SYM, Patient Assessment of Constipation–Symptom; VSAQ, Visual Scale Analog Questionnaire; CTSAT-Q, Chronic Constipation Treatment Satisfaction Questionnaire; CRQOL, Constipation-related Quality of Life; E-CIS, Elderly-constipation Impact Scale; PAC-QOL, Patient Assessment of Constipation–Quality of Life; OIC, opioid-induced constipation; PDA, personal digital assistant; IVRS, interactive voice response system; USA, United States of America; UK, United Kingdom.
Method of administration was assumed to be pen and paper unless reported otherwise.