Table 1.
PROM characteristics - Disability.
| PROM (Abbr.) | Primary language | Construct description | Target pop. | Intended context of use | Recall period | Response options | (sub)scale(s) (number of items) | Range of scores (worst-best) |
|---|---|---|---|---|---|---|---|---|
| IBD Disability Scale (IBD-DS)41 | English (AUS) | Limitations and restrictions to normal activity that a patient may experience because of disease, expressed in impaired body function and structures, activity limitation, participation restriction and interaction with environmental factors. | IBD | clinical practice and social services | 1 month | 5-level Likert and yes/no | Total score (58) Mobility (?) Self-care (?) Major life activities (?) Gastrointestinal-related symptoms (?) Mental-related symptoms (?) Enviromental-related issues (?) Support? (?) | NA NA NA NA NA NA NA NA |
| Crohn's Perceived Work Disability Questionnaire (CPWDQ)39 | Spanish (ES) | Disability is partial or total inability to perform social roles such as work activity in a manner consistent with norms or expectations, and is a potential consequence of disease. "Total" CD disability has two clear components: "acute" disability induced by disease activity, and permanent disability. Permanent disability is usually associated with active disease that does not respond to any treatment, or with sequelae of disease or of previous surgical treatment. For work disability, the impairment must be permanent or, at least, should have a low probablility of improvement. | CD | Awarding social benefits and medical research | 1 year | 4-level Likert scale | Total score (16) Clinical determinants (11) Social derterminants (5) | 64 - 16 NA NA |
| Short Crohn's Disease Work Diseability Questionnaire (sCDWDQ)40 | Spanish (ES) | Disability has been defined as chronic limitation(s) that interfere with the ability to engage in usual daily activities. Work-disability is defined as the inability to perform any substantial gainful work-related tasks because of a medically determinable physical or mental impairment. | CD | Clinical trials and clinical practice | 1 year | 4-level Likert scale | Total (9) | 36 - 9 |
| IBD Disability Index-14 self-report (IBDDI-14-s)42,43 | English (INT) | Problems associated with a disease involving body functions, body structures or activities and participation. I The decrement in functioning is the result of an interacion between underlying health conditions and contextual factors, namely environmental and personal factors. | IBD | Clinical trials and clinical practice | 1 week | Variable | Total score (14) | 100 - 0 |
| IBD Disability Index self-report (IBDDI-SR)44 | English (NZ/AUS) | Problems associated with a disease involving body functions, body structures or activities and participation.I The decrement in functioning is the result of an interacion between underlying health conditions and contextual factors, namely environmental and personal factors. | IBD | Clinical trials and clinical practice | 1 week | Variable | Total score (28) Overall health (1) Body functions (9) Body structures (2) Activities and participation (6) Environmental factors (14) | -80 - 22 -4 - 0 -31 - 2 -3 - 2 -24 - 0 -18 - 18 |
| IBD Disability Index Self-Report (IBDDI-SR-8)44 | English (NZ/AUS) | Problems associated with a disease involving body functions, body structures or activities and participation. I The decrement in functioning is the result of an interacion between underlying health conditions and contextual factors, namely environmental and personal factors. | IBD | Clinical trials and clinical practice | 1 week | Variable | Total score (8) | -26 - 6 |
| IBD Disk45 | English (INT) | Problems associated with a disease involving body functions, body structures or activities and participation. I The decrement in functioning is the result of an interacion between underlying health conditions and contextual factors, namely environmental and personal factors. | IBD | Clinical practice | 1 week | Numerical scale | Visual score (10) | 100 - 0 |
| Self-report disease activity | ||||||||
| Patient Harvey Bradshaw Index (pHBI)54 | Dutch (NL) | No clear description provided, probably: Disease flares can be intense and are frequently accompanied by increased pain, fatigue, and diarrhea (...) CD can challenge the well-being of patients and limit their daily functioning54. And: Over-all activity of Crohn's disease (...) incorporting factors considered as important indicators of disease activity by most knowledgable gastroenterologists34. | CD | Clinical trials | 1 week | Variable rating scales (range 0-4) or frequency | Total score (11) | >15 - 0 |
| Harvey Bradshaw mobile App (HBImApp)55 | Spanish (ES) | No clear description provided, probably: "CD is extremely unpredictable, characterized by periods of remission and activity.(…) Exacerbation is associated with symptoms, such as diarrhea, abdominal pain, and/or weight loss". | CD | Clinical practice | 1 day | Variable rating scales (range 0-4) or frequency or present/ absent | Total score (12) | >16 - 0 |
| Self-report Simple Clinical Colitis Activity Index (s-SCCAI)48 | English (UK) | Probably like SCCAI. SCCAI has no clear definition provided, only: Complete assessment of disease activity of UC involves symptomatic evaluation, physical examination, (...) laboratory indices, and sigmoidoscopic assessment. (…) devise an (...) index of disease activity using a small number of clinical criteria (..) not require physical examination, sigmoidoscopic evaluation, or laboratory indices36. | UC | Clinical trials | Not defined | Variable rating scales (range 0-4) | Total score (6) | 19 - 0 |
| Patient Simple Clinical Colitis Activity Index (p-SCCAI)46 | Dutch (NL) | "UC is a chronic, relapsing condition that is manifested as inflammation in the rectum and sometimes in the rest of the colon. UC is predominantly associated with symptoms such as abdominal pain, (bloody) diarrhea, weight loss, anemia, fatigue and fevers. Extracolonic features (..) can also occur." | UC | Clinical practice and clinical trials | 1 week | Variable rating scales or yes/no/ I don't know (range 0-3) | Total score (13) | 19 - 0 |
| German IBD activity index - CD (GIBDI-CD)56 | German (DE) | No clear description provided, only 'Disease activity'. | CD (excl. pouch or stoma) | Survey research | Variable | Variable rating scales (range 0-4) | Total score (8) | 21 - 0 |
| German IBD activity index - UC (GIBDI-UC)56 | German (DE) | No clear description provided, only 'Disease activity'. | UC or CD with pouch (excl. stoma) | Survey research | Variable | Variable rating scales (range 0-4) | Total score (7) | 21 - 0 |
| Manitoba IBD Index (MIBDI)57 | English (CA) | No clear description provided, only: patient-defined disease activity over longer periods of time." | UC and CD | Prospective research | 6 months | 6-Level Likert (a-f) | Single question | a - f |
| Mobile Health Index CD (mHI-CD)51 | English (USA) | No clear description provided, only "Disease activity". | CD | Home monitoring application | Not defined | Variable rating scales or yes/no | Total score (4) (weighted scoring fomula) | 14,2856 - 0 |
| Mobile Health Index UC (mHI-UC)51 | English (USA) | No clear description provided, only "Disease activity". | UC | Home monitoring application | Not defined | Variable rating scales | Total score (4) (weighted scoring formula) | 10,6773 - 0 |
| 6-point Score49 | English (USA) | Probably like Mayo Score. Mayo has no clear description provided, only: Patients daily recorded the frequency of their stools, any rectal bleeding, (...) a physician global-assessment score (the patient's daily record of abdominal discomfort and general sense of well-being and other observations, such as physical findings and the patient's performance status) (..) and the proctoscopic appearance37." | UC | Clinical trials | Not defined | 4-level Likert (0-3) | Total score(2) | 6 - 0 |
| Patient-reported ulcerative colitis severity index (PRUCSI)47 | English (USA) | Probably like Mayo Score. Mayo has no clear definition provided. Probably: "Patients daily recorded the frequency of their stools, any rectal bleeding, (...) a physician global-assessment score (the patient's daily record of abdominal discomfort and general sense of well-being and other observations, such as physical findings and the patient's performance status) (..) and the proctoscopic appearance37." | UC | Clinical trials | Undefined | Variable rating scales (range 0-4) | Total score (3) (weighted score formula) | 11,5155 - 0 |
| Self-Report Scale (SRS)50 | English (CA) | No clear description provided. Probably based on symptoms represented in original St. Mark's index38 in combination with laboratory indices and sigmoidoscopic findings. | UC | Clinical trials and clinical practice | 1 day | Variable rating scales (range 0-3) | Total score (7) | 13 - 0 |
| IBD Symptom Inventory - Long form (IBDSI-LF)58 | English (CA) | "Symptoms that could be used in both CD and UC (…) a wide range of symptoms which may vary in presentation among patients over time (…) such as fatigue, gas and blaoting, urgency of bowel movements, soiling, difficulties with weight, fever and sleeping (...) general health, abdominal pain, consistancy of bowel movements and IBD-related complications." | IBD | Clinical practice | 1 week | Variable rating, Likert of frequency scales (rescaled scoring range 0-4) | Total score (35)* Bowel symptoms (9) Abdominal discomfort (11) Fatigue (6) Bowel complications (3) Systemic complications (5) | 137 - 0 4 - 0 4 - 0 4 - 0 4,3 - 0 4 - 0 |
| IBD Symptom Inventory - Short form (IBDSI-SF)58 | English (CA) | "Symptoms that could be used in both CD and UC (…) a wide range of symptoms which may vary in presentation among patients over time (…) such as fatigue, gas and blaoting, urgency of bowel movements, soiling, difficulties with weight, fever and sleeping (...) general health, abdominal pain, consistancy of bowel movements and IBD-related complications." | IBD | Research or clinical practice | 1 week | Variable rating, Likert of frequency scales (rescaled scoring range 0-4) | Total score (24)* | 95 - 0 |
| Bowel symptoms (9) Abdominal and bodily discomfort (12) Fatigue (3) | 3,9 - 0 4 - 0 4 - 0 | |||||||
| Monitor IBD at Home questionnaire - CD (MIAH-CD)53 | Dutch (NL) | No clear description provided. Only: "(…) IBD activity should accurately reflect mucosal inflammation." | CD | Remote monitoring | 1 day | Rating scale (0 - >10) or yes/no or No/Yes, urgent/ Yes, very urgent | Total score (6) (weighted scoring formula) | 8,59 - 1,01 |
| Monitor IBD at Home questionnaire - UC (MIAH-UC)53 | Dutch (NL) | No clear description provided. Only: "(…) IBD activity should accurately reflect mucosal inflammation." | UC | Remote monitoring | 2 day | Rating scale (0 - >10) or yes/no or No/Yes, urgent/ Yes, very urgent | Total score (5) (weighted scoring formula) | 9,83 - 0 |
| Visual analog scale - UC (VAS-UC)52 | Japanese (JA) | "UC (…) causes diffuse mucosal injuries from the rectum toward the proximal colon (…) patients present symptoms such as visible blood in stools, diarrhea and abdominal pain." "symptoms (…) are expected to reflect or partly parallel the activity of the disease in the colorectum." | UC | Clinical practice | 1 day | Visual analog scale (0-10) | General condition (1) Bloody stools (1) Stool form (1) Abdominal pain (1) | 0 - 10 0 - 10 0 - 10 0 - 10 |
| IBD-Control (IBD-C)59 | English (UK) | The goal of therapy for inflammatory bowel diseases (IBD) is to achieve and maintain disease control and thereby optimise quality of life (QoL). Core domains in disease control are: physical, social, emotional and treatment. | UC and CD | Clinical practice | 2 weeks | yes/not sure/no (0-2) | IBD-C-8 sumscore (8) | 0 - 16 |
| Visual analog scale (0-100) | IBD-C-VAS (1) | 0 - 100 | ||||||
| Yes/not sure/no or better/ no change/worse | IBD-C individual questions (5) | NA | ||||||
| *Some questions have subquestions; some are not added in any total score or sumscore. | ||||||||
| IBD Questionnaire (IBDQ-32)60-66 | English (CA) | Health status, specifically: "Disease-related dysfunction in IBD patients" including identified domains by Mitchell et al: bowel function, systemic function, emotional function, social impairment and functional impairment85. | IBD (excl. proctitis and ileostomy) | Clinical trials | 2 weeks | 7-level Likert (1-7) | Total score (32) 49,50,52,53 Bowel symptoms (10) Systemic symptoms (5) Emotional function (12) Social function (5) | 32 - 224 10 - 70 7 - 35 12 -84 5 - 35 |
| IBD Questionnaire 5-Likert (IBDQ-5L)71 | Dutch (NL) | The quality of life of patients with a chronic disease, like inflammatory bowel disease, includes the patient's symptoms and physical functioning as well as psychosocial variables. | IBD (incl. ileostomy) | Clinical trials | 2 weeks | 5-level Likert (1-5) | Total score (32) Bowel symptoms (10) Systemic symptoms (5) Emotional function (12) Social function (5) | 32 - 160 5 - 50 5 - 25 12 -60 5 - 25 |
| UK IBD Questionnaire (IBDQ- 30)69-70 | English (UK) | Health-related quality of life is a subjective assessment of the patients' overall physical, mental, and social well-being as it relates to their own experience of ill health. | IBD (incl. proctitis) | Clinical trials | 2 weeks | 4-level Likert (1-4) | Bowel function I (6) Bowel function II (4) Systemic function (4) Emotional function (9) Social function (7) | 6 - 24 4 - 16 4 - 16 9 - 36 7 - 31 |
| Norwegian IBD Questionnaire (IBDQ-N)68 | Norwegian (N) | No clear description provided, probably like IBDQ-32. | IBD (excl. ileostomy) | Clinical trials | 2 weeks | 7-level Likert (1-7) | Total score (32) Bowel function I (7) Bowel function II (5) Emotional function I (11) Emotional function II (4) Social function (4) Single question (1) | 32 - 224 7 - 49 5 - 35 11 - 77 4 - 28 4 - 28 1 - 7 |
| German IBD Questionnaire (IBDQ-D)73 | German (DE) | No clear description provided, probably like IBDQ-32. | UC - IPAA patients | Clinical trials | 2 weeks | 7-level Likert (1-7) | Total score (32) | 32 - 224 |
| Short IBD Questionnaire 10-items (sIBDQ-10)72 | Englisch (UK) | No clear description provided, probably like IBDQ-32. | UC (excl. ileostomy and IPAA) | Clinical practice | 2 weeks | 7-level Likert (1-7) | Total score (10) Bowel scale (2) Systemic scale (2) Emotional scale (4) Social scale (4) | 10 - 70 2 - 14 2 - 14 4 - 28 2 - 14 |
| IBD Questionnaire 36-items (IBDQ -36)74 | English (CA) | No clear description provided, probably like IBDQ-32. | "Well" IBD | Clinical practice | 2 weeks | 7-level Likert (1-7) | Total score (36) Bowel symptoms (8) Systemic symptoms (7) Emotional function (8) Social impairment (6) Functional impairment (7) | 1 - 7 1 - 7 1 - 7 1 - 7 1 - 7 1 - 7 |
| Short IBD Questionnaire 9-items (sIBDQ-9)67 | Spanish (ES) | Health-related quality of life has been defined as the functional effect of an illness and its consequent therapy upon a patient, as perceived by the patient. | IBD | Clinical practice | 2 weeks | 7-level Likert (1-7) | Total score (9) | 0 - 100 |
| Health-related Quality of life | ||||||||
| Crohn's and Ulcerative Colitis Questionnaire (CUCQ-32)78,79 | English (UK) | No clear description provided. Probably like IBDQ-32. | IBD | Clinical trials and clinical practice | 2 weeks | 4-level Likert (0-3) or ordinal format (0-14) | Total score (32) Bowel (14)66 Psychological (9) Social (5) General (4) | 272 - 0 NA NA NA NA |
| Acute severe UC | Clinical trials and clinical practice | 2 weeks | 4-level Likert (0-3) or ordinal format (0-14) | Bowel (5)67 Psychological (10) Social (6) General (11) | NA NA NA NA | |||
| Crohn's and Ulcerative Colitis Questionnaire 8-items (CUCQ-8)78 | English (UK) | No clear description provided. Probably like CUCQ-32. | IBD | Clinical trials and clinical practice | 2 weeks | 4-level Likert (0-3) or ordinal format (0-14) | Total score (8) | 90 - 0 |
| Edinburgh IBD Questionnaire (EIBDQ)76 | English (UK) | No clear description provided, only: "the functional impact of an illness, and its consequent therapy, upon the patient, as perceived by the patient." | IBD | Clinical practice | Variable | 4-level Likert or Yes/No | Disease scale (5) Bowel scale (6) Information (2) | Not specified Not specified Not specified |
| Padova Quality of Life Questionnaire (PQoLQ)75 | Italian (I) | No clear description provided, only: "quality of life (QOL) is a somewhat complex and elusive concept, which has been defined as the possibility of attaining satisfaction from the activities of daily life, and is therefore a highly subjective value judgement." | IBD (excl. total colectomy) | Clinical practice | 2 weeks | 4-level Likert (0-3) | Total score (29) Intestinal symptoms (8) Systemic symptoms (7) Emotional function (9) Social symptoms (5) | 87 - 0 24 - 0 21 - 0 27 - 0 15 - 0 |
| IBD Quality of Life Questionnaire (IBD-QOL)77 | Chinese (CN-ML) | Patients' subjective perception of IBD, the impacts on daily life and the physical, mental and and social aspects of well-being. | UC and CD (excl. ostomies) | Clinical trials | 2 weeks | 5-level Likert (1-5) | Total score (22) Social function (5) Emotional function (6) Symptoms and discomfort (5) Bowel symptoms and its influences (6) | 22 - 110 5 - 25 6 - 30 5 - 25 6 - 30 |
| Function-related Quality of Life Instrument (Func-QoL)82 | English (USA) | The effects of accidents, disease and treatments on an individual's ability to both perform and enjoy the many functions and activities including work, recreation, household management and family life. | UC | Clinical trials | Not defined | Visual analog scale (0-10) or frequency | Disease specific parameters (5) (Trips to the toilet, stool consistency, rectal bleeding, abdominal/rectal pain, urgency) General parameters (7) (Ability to sleep, sexual relationship, outdoor activities, social activities, indoor activities, work/occupation, hobbies/recreation) | 10 - 0 Change score per individual item 10 - 0 Change score per individual item |
| Short Health Scale (SHS)81 | Swedish (SE) | Health-related quality of life is a measure of patients' experience of how illness or treatment interferes with life. Domains within this health status are biological variables, symptom burden, functional status (psychological and mental capacity and social activities), disease-related worry and general well-being. | UC | Clinical trials and clinical practice | Not defined | Visual analog scale (0-100) | Symptom burden (1) Functional status (1) Disease-related worry (1) General well-being (1) | 100-0 100-0 100-0 100-0 |
| Crohn's Disease burden thermometer (CD Burden)86 | English (USA) | No clear description provided, probably: symptom burden is the difference between the current health and the anticipated current health without CD symptoms. Treatment burden is the difference between current health and the anticipated current health if all things related to their CD treatment could be stopped while maintaining current health. | CD | Clinical practice | 'Current' | Visual analog scale (0-100) | Symptom burden (1) Treatment burden (1) | 0 - 100 0 - 100 |
| Crohn's Life Impact Questionnaire (CLIQ)83 | English (UK) | Life derives its quality from the ability and capacity of an individual to meet certain human needs. Rather than focus on symptoms and activity limitations, the needs-based model looks at how these impairments affect need fulfilment. | CD | Clinical trials and clinical practice | Today | True/ Not true (1-0) | Total score (27) | 27 - 0 |
| Health Status Scale Crohn's Disease (HSS-CD)80 | English (USA) | No clear description provided, both: "the scales were standardized to (…) includes health care use, daily function, and psychological distress." and "Health status is a quantifiable, multidimentional concept that incorporates the person's perception of illness, functional status, and phychological concomitants in addition to disease activity." | CD | Clinical practice and clinical trials | Variable | Variable | Composit score CD (10) (weighted scoring formula) | 100 - 0 |
| Health Status Scale Ulcerative Colitis (HSS-UC)80 | English (USA) | No clear description provided, both: "the scales were standardized to (…) includes health care use, daily function, and psychological distress." and "Health status is a quantifiable, multidimentional concept that incorporates the person's perception of illness, functional status, and phychological concomitants in addition to disease activity." | UC | Clinical practice and clinical trials | Variable | Variable | Composit score UC (9) (weighted scoring formula) | 100 - 0 |
| Abbreviations: AUS: Australia; CA: Canada; CD: Crohn’s disease; CN-ML, Chinese mainland; DE: Germany. ES, Spain; I: Italy. IBD: inflammatory bowel disease; INT, internationally developed; IPAA, ileal pouch-anal anastomosis; JA:Japan; NL: Netherlands; N: Norway. NA, not available; NL: Netherlands. NZ: New Zealand. Pop: population; PROM, Patient-Reported Outcome Measure; SE: Sweden; UC: Ulcerative colitis; UK: United Kingdom; USA: United States of America. |