From: Minimal important differences for fatigue patient reported outcome measures—a systematic review
Instrument/scale (score range) | Citation/Population | Design | Anchor-based MID | Distribution-based MID | Triangulation MID | |||
---|---|---|---|---|---|---|---|---|
Anchor | Global change (% of scale range) | Improved | Worsened | |||||
Multidimensional scales | ||||||||
MFI (20–100) | Goligher et al. 2008 SLE (n = 80) | Cross-sectional | GRS (7-step) Paired comparisons | 11.5 (14 %) | 9.6 | 12.8 | ||
Pouchot et al. 2008 RA (n = 61) | Cross-sectional | GRS (7-step) Paired comparisons | 13.3 (17 %) | 6.8 | 9.5 | |||
FSS (1–7) | Goligher et al. 2008 SLE (n = 80) | Cross-sectional | GRS (7-step) Paired comparisons | 0.6 (10 %) | 0.08 | 1.2 | ||
Pouchot et al. 2008 RA (n = 61) | Cross-sectional | GRS (7-step) Paired comparisons | 1.2 (20 %) | 0.4 | 1.0 | |||
Robinson et al. 2009 MS (n = 249) | Cross-sectional | Disease duration, Expanded Disability Status Scale, Patient Assessment of MS Impact, MS Functional Composite | 0.5–1.1 (8–18 %) | ES 0.3–0.8 | 1 | |||
MAF (1–50) | Goligher et al. 2008 SLE (n = 80) | Cross-sectional | GRS (7-step) Paired comparisons | 5.0 (10 %) | 1.4 | 8.9 | ||
Pouchot et al. 2008 RA (n = 61) | Cross-sectional | GRS (7-step) Paired comparisons | 9.2 (19 %) | 5.4 | 8.3 | |||
CFS (0–33) | Goligher et al. 2008 SLE (n = 80) | Cross-sectional | GRS (7-step) Paired comparisons | 2.3 (7 %) | 0.7 | 3.2 | ||
Pouchot et al. 2008 RA (n = 61) | Cross-sectional | GRS (7-step) Paired comparisons | 3.3 (10 %) | 1.4 | 3.5 | |||
FIS (0–160) | Rendas-Baum et al. 2010 MS (n = 184) | Cross-sectional | Expanded Disability Status Scale (EDSS), SF-36, EQ-5D | 9–24 15.5 (10 %) | 4.8 (1 SEM), 9.6 (2 SEM) 11.6 (1/3 SD), 17.3 (½ SD) | 10–20 | ||
TOI-F (0–108) | Cella et al. 2002 Cancer (n = 2,583) | Cross-sectional Longitudinal 3 studies, follow-up: 3 d - 12 m | Performance status, haemoglobin level, response to treatment | 4.8–26.6 (4–25 %) | 4.2 (1 SEM), 10.5 (½SD) | 5.0 | ||
PQ (12–60) | Baró et al. 2011 Cancer (n = 437) | Longitudinal Follow-up: 3 m | Haemoglobin level | 3.7 | 3.5 | |||
SCFS (6–30) | Schwartz et al. 2001 Cancer (n = 103) | Longitudinal Follow-up: 2 d | GRS (7-step) | 5.0 (21 %) | 2.1 | 5.7 | ||
FAsD (1–5) | Matza et al. 2013 Depression (n = 96) | Longitudinal Follow-up: 6 w | BFI, ESS, CGI-S, Patient’s perception of change | 0.3–0.6 | 0.2–0.3 | |||
NFI-MS (0–30, 0–24 and 0–12 resp.) | Mills et al. 2012 MS (n = 208) | Longitudinal Follow-up: 6–8 w | Global perceived change item (5-step) | 2.5 (SS) (8 %) 2.4 (PS) (10 %) 0.8 (CS) (7 %) | ||||
Unidimensional scales or subscales | ||||||||
MFI sbscales: GF, PF, RA, RM and MF (4–20) | Purcell et al. 2010 Cancer (n = 210) | Longitudinal Follow-up: 6 w post treatment | Score change pre- and post-radiotherapy | GF: 2.1 (13 %) PF: 2.0 (13 %) RA: 2.4 (15 %) RM: 1.6 (10 %) MF: 1.4 (9 %) | 2 for each subscale | |||
U-FIS (0–66) | Twiss et al. 2010 MS (n = 911) | Longitudinal Follow-up: 12 m | EQ-5D | 6.5 | 4.7 | 4.2–7.0 (ES 0.3–0.5) 2.4 (1 SEM) | ||
FAS (10–50) | de Kleijn et al. 2011 Sarcoidosis (n = 321) | Longitudinal Follow-up: 12 m | WHOQOL-BREF/Physical health domain, ROC | 3.5 (9 %) | 3.0 | 3.8 | 4.2 (ES 0.5) 3.6 (1 SEM) | 4 |
SF-36 VT (0–100) | Bjorner et al. 2007 Several disease conditions (n = 3,445) | Cross-sectional | Regression analyses using age, gender, race, disease condition and functional outcomes | 5/group level 10/individual level | ||||
Goligher et al. 2008 SLE (n = 80) | Cross-sectional | GRS (7-step) Paired comparisons | 10.7 (11 %) | 7.3 | 18.3 | |||
Kosinski et al. 2000 RA (n = 693) | Longitudinal Follow-up: 6 w | Patient global assessment, Physician global assessment, pain, swelling, tenderness | 4.9–11.1 (5–11 %) | |||||
Pouchot et al. 2008 RA (n = 61) | Cross-sectional | GRS (7-step) Paired comparisons | 14.8 (15 %) | 11.3 | 11.9 | |||
Spiegel et al. 2005 Hepatitis C virus | Systematic review Delphi method | ES data from included studies | ES of 0.2 Range 0.15–0.25 | 4.2 Range 3–5 | ||||
Ward et al. 2015 RA (n = 249) | Longitudinal Follow-up: 1–4 m | HAQ, CES-D, Health transition item of SF36, Global transition item | 11.0–20.0 (11–20 %) | |||||
Wyrwich et al. 2003 Chronic obstructive pulmonary disease | Delphi method | Patient change scenarios and SF36 data | 12.5 | |||||
Wyrwich et al. 2004 Coronary artery disease/congestive heart failure | Delphi method | Patient change scenarios and SF36 data | 18.8 Range 18.8–25 | |||||
FACIT-Fatigue (0–52) | Cella et al. 2002 Cancer (n = 2,583) | Cross-sectional Longitudinal 3 d - 12 m | Performance status, haemoglobin level, response to treatment | 3 (6 %) | 3 | |||
Cella et al. 2005 RA (n = 271) | Longitudinal Follow-up: 24 w | VT/SF-36, MAF | 3–4 (6–8 %) | 4.10 (1 SEM) 2.2–5.5 (ES 0.2–0.5) | 3–4 | |||
Goligher et al. 2008 SLE (n = 80) | Cross-sectional | GRS (7-step) Paired comparisons | 5.9 (11 %) | 2.8 | 9.1 | |||
Lai et al. 2011 SLE (n = 254) | Longitudinal Follow-up: 12–52 w | Physician-reported anchors (Physician GA) | 3–7 (6–13 %) | 2.7 (1 SEM) 4.6 (1/3 SD), 6.8 (½SD) | 3–6 | |||
Pouchot et al. 2008 RA (n = 61) | Cross-sectional | GRS (7-step) Paired comparisons | 8.3 (16 %) | 6.8 | 5.2 | |||
Reddy et al. 2007 Cancer (n = 194) | Longitudinal Follow-up: 8 d | Global Benefit Score (7 step) | 10 | |||||
FACT-An Fatigue (0–80) | Patrick et al. 2003 Cancer (n = 375) | Longitudinal, Follow-up: pre and post chemotherapy | Haemoglobin level Regression analysis | 4.2 | ||||
POMS-F (0–28) | Schwartz et al. 2002 Cancer (n = 103) | Longitudinal Follow-up: 2 d | GRS (7-step) | 5.6 (20 %) | 2.1 | 5.7 | ||
EORTC QLQ-C30 Fatigue Subscale (0–100) | Bedard et al. 2013b Cancer (n = 276) | Longitudinal Follow-up: 1 m | Overall QoL | 24.5 | 19.7 (1 SEM) 6–15 (0.2–0.5 SD) | |||
Bedard et al. 2014 Cancer (n = 369) | Longitudinal Follow-up: 1 m | Overall QoL 1–7 Overall health anchor | 13.6–17.3 | 1.8 (1 SEM) 6.7–16.8 (0.2–0.5 SD) | ||||
Kvam et al. 2010 Multiple myeloma (n = 239) | Longitudinal Follow-up: 3 m | Global rating of change (7-step but categorized into 3) | 13.5 | 8.6 | ||||
Maringwa et al. 2011a Brain cancer (n = 941) | Cross-sectional and longitudinal | WHO Performance Status and MMSE | 12.4 | 8.9 | 10.0 (1 SEM) | |||
Maringwa et al. 2011b Lung cancer (n = 812) | Cross-sectional and longitudinal | Physician-rated WHO PS and weight change | 14.1 | 5.7 | 11 (1 SEM) | |||
Zeng et al. 2012 Cancer (n = 93) | Longitudinal Follow-up: 1 m | KPS clinical marker | 11.4 | 7.8 | 3.0–3.1 (1 SEM) 5.8–14–7 (0.2–0.5 SD) | |||
SIS (0–100) | Lasch et al. 2009 MDD (n = 379) | Longitudinal Follow-up: 8 w | Clinician rated tool (7-step) on severity and improvement | E/F: 11.9 (12 %) MF: 13.3 (13 %) | 8.7 (½SD) 10.6 (½SD) | |||
CRQ (1–7) | Schünemann et al. 2005 Chronic obstructive pulmonary disease | Systematic review | CRQ data from5 studies, patient global ratings anchors and distributions based MIDs | 0.5–0.6 (8–10 %) | 0.47–0.54 (1 SEM) | 0.5 | ||
Wyrwich et al. 2003 Chronic obstructive pulmonary disease | Delphi method | Patient change scenarios and CHQ data | 2 | |||||
CHQ (4–28) | Wyrwich et al. 2004 Coronary artery disease/congestive heart failure | Delphi method | Patient change scenarios and CHQ data | 3 Range 3–4 | ||||
QOLIE-31 Energy/fatigue subscale (0–100) | Borghs et al. 2012 Epilepsy (n = 1,035) | Longitudinal study of 3 RCTs Follow-up: 12 w | Patient global impression of change (PGIC) Regression analysis | 7.5 (8 %) | 5.8 (0.3 ES) 9.4 (1 SEM) | |||
Single item measure | ||||||||
VAS Fatigue Single item (0–100) | Colangelo et al. 2009 SLE (n = 202) | Longitudinal Follow-up: 7.5 m | Self-rated health (5 step) | 13.9 | 9.1 | |||
George & Pope 2011 Sjögren’s syndrome (n = 40) | Longitudinal Follow-up: ≤ 16 m | Self-rated health (5 step) | 6.2 | 15.2 | ||||
Kwok & Pope 2010 PsA (n = 200) | Longitudinal Follow-up: ≤12 m | Self-rated health (5 step) | 8.2 | 3.6 | ||||
Sekhon et al. 2010 Systematic sclerosis (n = 109) | Longitudinal Follow-up: 7.5 m | Self-rated health (5 step) | 10.0 | 3.8 | ||||
Wells et al. 2007 RA (n = 1,043) | Longitudinal Follow-up: 6–12 m Delphi method | HAQ, Patient Global assessment of disease and pain | 6.7–17 (7–17 %) | 10 | ||||
Wheaton & Pope 2010 SpA (n = 140) | Longitudinal Follow-up: 5 m | Self-rated health (5 step) | 1.4 | 14.4 | ||||
VAS Fatigue Single item (0–10) | Khanna et al. 2008 RA (n = 307) | Longitudinal Follow-up: 5.9 m | Retrospective anchor (5-step) | 0.8–1.1 | 1.1–1.3 | Improved: ES = 0.39 Worsened: ES = 0.44 | ||
GRS Single item (0–10) | Goligher et al. 2008 SLE (n = 80) | Cross-sectional | GRS (7-step) Paired comparisons | 1.3 (13 %) | 0.3 | 1.5 | ||
Pouchot et al. 2008 RA (n = 61) | Cross-sectional | GRS (7-step) Paired comparisons | 2.0 (20 %) | 0.9 | 1.5 | |||
Schwartz et al. 2001 Cancer (n = 103) | Longitudinal Follow-up: 2 d | GRS (7-step) | 1.1 (11 %) | |||||
ESAS fatigue Single item (0–10) | Bedard et al. 2013a Cancer (n = 421) | Longitudinal Follow-up: 4–12 w | Well-being | 0.1–1.3 | 1.0–1.8 | 0.1 (1 SEM) 0.5–1.4 (0.2–0.5 SD) | ||
Reddy et al. 2007 Cancer (n = 194) | Longitudinal Follow-up: 8 d | Global Benefit Score (7 step) | 4 | |||||
ITP-PAC (0–100) | Mathias et al. 2009 ITP (n = 125) | Longitudinal Follow-up: 4 w | Global assessment of change items (15-step) | 15.0 (15 %) | ES = 0.57 | |||
PROMIS fatigue item bank scales | ||||||||
PROMIS Fatigue-17 (17–85) | Yost et al. 2011 Cancer (n = 101) | Cross-sectional and longitudinal Follow-up: 6–12 w | 23 anchor measures | T-score MID: 2.5–4.5 Raw-score MID: 4.0–8.0 (6–12 %) | Cross-sectional: ES 0.34–0.79 Longitudinal: ES 0.27–0.52 | |||
PROMIS Fatigue-7 (7–35) | Yost et al. 2011 Cancer (n = 101) | Cross-sectional and longitudinal Follow-up: 6–12 w | 23 anchor measures | T-score MID: 3.0–5.0 Raw-score MID: 2.0–3.0 (7–11 %) | Cross-sectional: ES 0.24–0.76 Longitudinal: ES 0.24–0.51 |