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Table 2 Characteristics of included PROMs

From: Patient-reported outcome measures used in patients with primary sclerosing cholangitis: a systematic review

PROM Construct Therapeutic area Domains Total No. of items Scoring method Recall period Administration Completion time Data collectiona Cost & permissionb
15 D © HRQOL Generic Mobility,Vision,Hearing, Breathing, Sleeping, Eating, Speech, Elimination, Usual Activities, Mental function,Discomfort, symptoms, Depression, Distress, Vitality, Sexual Activity 15 1 to 5 levels Present health status Self-administered 5–10 min PP A, B
5-D Itch Pruritus Severity of symptoms Duration, Degree, Direction, Disability, Distribution 5 0–5 (0 being least problematic and 5 most problematic) Last 2 weeks Self-administered < 5 min PP Unknown
BDI Psychological functioning (incl. coping) Psychology/ Behaviour Cognitive-affective, Somatic 21 Higher score = greater depression Last 2 weeks including today Self-administered/ Interviewer-administered 5–10 min E, PP B,D
CGQOL HRQOL Disease specific (IBD) Unknown 3 0–1.0 (1 being the best) Unknown Unknown Unknown PP Unknown
CLDQ HRQOL Digestive System Diseases Abdominal symptoms, Fatigue, Systemic symptoms, Activity, Emotional function, Worry 29 Higher score = better QoL Last two weeks Self-administered 10 min E, PP B,D
COMPASS Autonomic nervous system diseases Signs and symptoms Orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupilometer 31 Higher score = higher autonomic symptom severity In past year/ past 5 years Self-administered No information PP No information
EQ -5D HRQOL Generic Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression 5 + VAS (20 cm) Higher score = better QoL Today Interviewer-administeredProxy-ratedSelf-administered A few minutes E, PP, IVR, T B,D
ESS Sleep disorder Signs and symptoms Sleep 8 Higher score = higher sleepiness Over recent times Self-administered 2–3 min E, PP A,B
FFSS HRQOL Signs & symptoms Fatigue 9 High score = higher fatigue Past two weeks Self-administered <  5 min E, PP B,D
FIS Symptoms of fatigue Pathological Conditions, Signs and Symptoms Cognitive functioning, Physical functioning, Psychosocial functioning 40 Lower score = less fatigue Past four weeks Self -administered 10 min PP A,B
FSFI Signs and symptoms Female Urogenital Diseases & Pregnancy Desire, Arousal, Lubrication, Orgasm, Global satisfaction, Pain 19 Higher score = better functioning During the past 4 weeks Self-administered Information not found E, PP C
Grading system for fatigue & pruritus Fatigue and Pruritus Severity of symptoms Unknown Unknown Pruritus, grades 0 -no, 1-mild, 2- sleep interference,3-
substantial sleep disturbance
Fatigue, grade 0- no; 1- present, but no interference with activity; 2-extra rest required & activity limited 3- patient unable to work a full day.
Unknown Unknown Unknown Unknown Unknown
GSRS Signs and symptoms Signs & symptoms, Digestive system diseases Abdominal pain syndrome, Reflux syndrome, Indigestion syndrome, Diarrhoea syndrome, Constipation syndrome 15 Lower score-better QoL Last week Self-administered 10 min PP B,D
HADS Signs and symptoms Nervous System Diseases Mental Disorders Anxiety, Depression 14 Lower score = better QoL In the past week Self-administered 2–5 min E, PP C
HHHQ Diet Dietary habits Patient demographics, Education, Medical surgical history and environmental exposure including dietary habits 370 questions Unknown Unknown Self-report Unknown Unknown Unknown
IDS-SRS 30 Signs and symptoms Psychiatry/Psychology/Behaviour Vegetative features, Cognitive changes, Mood disturbance, Endogenous symptoms, Anxiety symptoms 30(28 initial version) Higher score = higher severity Past 7 days Clinical-rated, interviewer-administered, self-administered 10–15 min E, IVR, PP C
IIEF HRQOL Erectile Dysfunction Erectile function, Orgasmic function, Sexual desire, Intercourse satisfaction, Overall satisfaction 15 Higher score = better QoL. Scores by dimension Past 4 weeks Self-administered 15 min PP B,D
LDH Alcohol consumption patterns Intake assessment Consumption levels (quantity), frequency of use, variability in consumption, types of beverages, drinking pattern, solitary versus social drinking, time of the day alcohol consumption Unclear Scored by hand or calculator Unknown Unknown 20 min Unknown Cost nominal (copyright)
LDQOL 1.0 HRQOL Digestive System Diseases - Generic core SF-36v2
- Disease-targeted scales:
Liver disease-related symptoms,
Effects of liver disease, Concentration/Memory, Health distress, Sleep, Loneliness, Hopelessness, Stigma of liver disease, Sexual functioning/problems
72 Higher score = Better HRQOL. The past 4 weeks; Presently (for few items) Self-administered 18 (+/− 9) min PP D
MFI Signs and symptoms Pathological conditions, signs and symptoms General fatigue, Physical fatigue, reduced activity, Reduced motivation, Mental fatigue 20 Lower score = better QoL Lately Self-administered 5 min PP B
NIDDK-QA HRQOL Patients undergoing Liver transplant Liver disease symptoms, physical functioning,
health satisfaction & overall well-being (OWB)
47 Higher scores indicate better QOL Unknown Unknown Unknown Unknown Unknown
OS Functional outcome IPAA or IRA Bowel movements, urgency, evacuation difficulties, soiling or seepage, perianal/stomal soreness, protective pad, dietary restrictions and social handicap Unclear best 0, worst 15 Unknown Unknown Unknown Unknown Unknown
PBC-27 HRQOL Disease specific Symptoms, Dryness,Itch, Fatigue, Cognitive, Emotional and Social 40 Higher scores = greater symptoms impact & poorerHRQOL. Last four weeks Self-completion <  5 min PP Unknown
PBC-40 HRQOL Disease specific Other Symptoms domain, Itch, Fatigue, Cognitive, Social and Emotional 27 Higher scores = greater symptoms impact & poorerHRQOL. Last four weeks Self-completion 5 min PP Free access
PedsQL 4.0 HRQOL Generic Physical functioning, Emotional functioning, Social functioning,school functioning 21 to 23 Higher score = better QoL Standard version: past one month. Acute version: past 7 days Interviewer-administered
5 min PP A,B
PGWB HRQOL Generic Anxiety, Depression mood, Positive well-being, Self-control, General health, Vitality 22 Higher score = better QoL Standard version = past month/ acute version = last week/ last four weeks Self-administered/Interviewer-administered 15 min PP  
PHQ-9 Depression Severity of depression Nine questions on symptoms 10 Depression severity:1–4: None; 5–9: Mild; 10–14: Moderate, 15–19: Moderately severe, 20 to 27: Severe over past 2 weeks Self-completion 2 to 5 min PP Unknown
Pruritus numerical rating scale Pruritus Severity of symptoms Unknown Unknown Numerical rating scale 0–10 (0 for having no symptoms and 10 for having the worst imaginable pruritus) Unknown Unknown Unknown Unknown Unknown
PSC PRO HRQOL Disease specific PSC symptoms, Physical function, Activities of Daily Living, Work Productivity, Role Function, Emotional Impact, Social/Leisure Impact, Q uality of Life, Total Impact of Symptoms 42 Module 1: 0–10 scale; Module 2 has 7 four item domains: 1–5 scale, summed within dmains and domain mean summed to give overall impact score Module 1–24 h recall Self-administered 7–15 min E, PP Unknown
Rome ll modular questionnaire Symptoms Functional bowel disorder Esophageal symptoms, Gastroduodenal symptoms, Bowel symptoms, Abdominal pain symptoms, Biliary symptoms and Anorectal symptoms Unknown Unknown Unknown Unknown Unknown Unknown Unknown
SADS Signs and symptoms Depression Depressive mood and ideation, Endogenous (ie. Melancholic, vital or vegetative) features, Depressive syndrome, Suicidal ideation and behaviour 30 Unknown Past week only Unknown Unknown Unknown Unknown
SF-36 HRQOL Generic Physical Functioning,
Role-Physical, Bodily Pain, General Health,Vitality, Social Functioning, Role-Emotional,Mental Health
36 0 to 100, higher score = better health status Standard version 4 weeks / Acute version 1 week Self-administered/Interviewer-administered 5–10 min E, C, IVR, T, PP B
SF-6D Utilities & Health states Generic- preference based measure Physical functioning, role limitation, social functioning, pain, mental health, vitality Unknown 0.296-most severe problems 1.0-no problems Unknown Unknown Unknown Unknown Unknown
SIBDQ HRQOL Digestive System Diseases Bowel symptoms, systematic symptoms, Emotional function, Social function 10 1 to 7, higher score = better QOL Last two weeks Self-administered/Interviewer-administered 5 min E, PP D
VAS Fatigue and Pruritus Severity of symptoms Fatigue, Energy, Pruritus Pruritus: 10 cm line Pruritus 0 -no pruritus / 10- worst pruritus imaginable Right now Self-administered Vas: Fatigue < 2 min PP Free access
WHOQOL-BREF HRQOL Generic Physical, Psychological, social relationship, Environment, +  2 overall QOL & general health status 26 Higher score = better QoL Last 2 weeks Interviewer-administered, self-administered 5 min self-administration, 15–20 min interviewer-administration PP D
  1. 15 D 15-dimensional health-related quality of life measure, 5-D Itch Five dimensions Itch, BDI: Beck Depression Inventory, CGQOL Cleveland global quality of life questionnaire, CLDQ Chronic liver disease questionnaire, COMPASS Composite Autonomic Symptom Scale, EQ. 5D EuroQol EQ. 5D, ESS Epworth Sleepiness Scale, FFSS Fisk Fatigue Severity Scale, FIS Fatigue Impact Scale, FSFI Female Sexual Satisfaction Index, GSRS Gastrointestinal Symptom Rating Scale, HADS Hospital anxiety and depression scale, HBI Harvey-Bradshaw Index, HHQ Health Habits and History Questionnaires, HRQOL Health-related quality of life, IBD Irritable Bowel Syndrome, IDS-SR30 30-item Inventory of Depressive Symptomatology-self report, IIEF International index of erectile function, LDH Lifetime drinking history, LDQOL Liver Disease Quality of Life Questionnaire, MFI Multidimensional Fatigue Inventory, NIDDK-QA National institute of diabetes and digestive and kidney disease liver transplant questionnaire, No. Number, OS Oresland Scale, PBC-40 Primary Biliary Cirrhosis, PF Pouch Function Questionnaire, PGWB Psychological general well-being index, PHQ-9 Patient Health Questionnaire, PSC PRO Primary Sclerosing Cholangitis patient-reported outcome, QoL Quality of Life, SADS Schedule for Affective Disorders and Schizophrenia, SF-36 Short form 36, SIBDQ Short Inflammatory Bowel Disease Questionnaire, UCAI UC Activity Index, VAS Visual Analogue Scale, WHOQOL-BREF World Health Organization Quality of Life assessment instrument
  2. aPP: Paper & pen, E: E-version, IVR: Interactive Voice Response, T: Telephone, C: Computer
  3. bA: Free access to academic/non-profitable research, B: Fees for commercial/pharmaceutical companies/academics, C: Free access to public domain, D: Contact author / licence / signature of a contract or agreement