Background
Methods
Literature searches
Study selection
Inclusion criteria | Exclusion criteria | |
---|---|---|
Population | Defined population of English-speaking participants aged 18 years (adults) with PADa
Patients with rest pain; claudication; vascular spasms; ischaemic ulceration; amputation; necrosis or gangrene of the limb due to PAD | Undefined population or Non-English speaking adults with PAD Patients with rest pain; claudication; vascular spasms; ischaemic ulceration; amputation; necrosis or gangrene of the limb due to any cause other than PAD |
Interventions | No intervention or any intervention indicated for PAD | Intervention, not intended for the management of PAD |
Outcomes | Original version of PROMs in English including • generic or preference-based measures e.g. EQ-5D, SF-6D, SF-36; • directly elicited preference-based measures e.g. time-trade-off (TTO), standard gamble (SG) utility values; condition-specific outcome measures; • functional outcome measures | Original version of PROMs in English including • Outcome measures of patient satisfaction or experience • Outcome measures obtained from proxies, carers or health providers Non-English versions of PROMs English translations of non-English PROMs |
Study type | Validation studies of a relevant PROM addressing • Validity; • Reliability; • Responsiveness or acceptability Publication in English | Studies of linguistic validation of PROMs Review articles, letters, commentaries, abstracts Non-English publications Unpublished studies |
Data extraction
Quality assessment
Domain | Criteria |
---|---|
Test re-test reliability |
Reliability is the ability of a measure to reproduce the same value on two separate administrations when there has been no change in health.
The intra-class correlation/ weighted kappa score should be ≥ 0.70 for group comparisons and ≥ 0.90 if scores are going to be used for decisions about an individual based on their score [2]. The mean difference (paired t test or Wilcoxon signed-rank test) between time point 1 (T1) and time point 2 (T2) and the 95% CI should also be reported. |
Internal consistency |
Internal consistency is an assessment of whether the items are measuring the same thing.
A Cronbach’s alpha score of ≥ 0.70 is considered good and it should not exceed ≥0.92 for group comparisons as this is taken to indicate that items in the scale could be redundant. Item total correlations should be ≥0.20 [14]. |
Content validity |
Content validity measures the extent to which the items reflect the domains of interest in a way that is clear.
To achieve good content validity, there must be evidence that the instrument has been developed by consulting patients, experts as well as undertaking a literature review. |
Construct validity |
Construct validity assesses how well an instrument measures what it was intended to measure.
|
Criterion validity |
Criterion validity assesses the degree of empirical association of the PROM with external criteria or other measures.
A good argument should be made as to why an instrument is a gold standard and correlation with the gold standard should be ≥ 0.70 [15]. |
Responsiveness |
Responsiveness assesses the ability of the PROM to detect changes when changes are expected.
Available methods to measure responsiveness include t-tests, effect size, standardised response means or responsiveness statistics, Guyatts’ responsiveness index. Standardised effects sizes and SRMs of less than 0.2 are considered small, 0.5 moderate, and 0.8 [17]. There should be statistically significant changes in score of an expected magnitude [8]. |
Floor-ceiling effects | A floor or celling effect is considered if 15% of respondents are achieving the lowest or the highest score on the instrument, respectively [15]. |
Acceptability | Acceptability is reflected by the completeness of the data supplied. 80% or more of the data should be complete [16]. |
Data synthesis and analysis
Results
Study characteristics
Author year, country | Reported PROM (s) | Clinical presentation (Sample size) (Ankle brachial index cut-off) | Age (years) | Gender (% males) | Timing of PROM (s) assessment | Concomitant treatment |
---|---|---|---|---|---|---|
Chetter 1997, UK [19] | EQ-5D SF-36 NHP | Peripheral arterial disease (n = 235) | 68◊
| 61 | Baseline, week 1 | NR |
(NR) | ||||||
Chong 2002, UK [20] | EQ-5D ICQ SF-36 WIQ | Intermittent claudication (n = 124) | 71◊
| 61 | Baseline, week 2, month 3 | conservative medical treatment; percutaneous transluminal angioplasty |
(≤0.9) | ||||||
Coyne 2003, USA [26] | EQ-5D PAD symptom scale, SF-36, WIQ (self-administered and telephone-administered) | Peripheral arterial disease (n = 60) | 67 | 78 | Baseline, day 4, 7, 14 and 28 | NR |
(<0.9, at rest) | ||||||
Gulati 2009, UK [21] | SF-36 SF-8 | Peripheral arterial disease (n = 193) | 66◊
| 70 | Baseline; at week 2 | NR |
(NR) | ||||||
Izquierdo-Porrera 2005, USA [27] | SF-36 WIQ | Intermittent claudication | 71 | 91 | Baseline, at week 1 | exercise rehabilitation |
(n = 80) (<0.97, at rest; < 0.85, 0.85 during recovery from exercise)) | ||||||
Mazari 2010, UK [25] | EQ-5D SF-6D VascuQoL | Intermittent claudication (n = 178) | 70◊
| 60 | Baseline, at month 1, 3, 6, 12 | transluminal angioplasty, supervised exercise program, or combined treatment |
McDermott 1998, UK [28] | WIQ | Intermittent claudication (n = 146a) | 71.4 | 57 | Baseline | NR |
(≤0.9, at rest) | ||||||
Mehta 2006b, UK [22] | EQ-5D SF-36 SIPic VascuQol | Intermittent claudication (n =70) | 70◊
| 54 | Baseline, at month 6 | Percutaneous transluminal angioplasty (n =47); Conservative medical therapy (n = 23). |
(NR) | ||||||
Morgan 2001, UK [23] | SF-36 VascuQol | Peripheral arterial disease (n = 39) | 67◊
| 62 | Baseline, at week 4 | general advice, medical treatment, angioplasty (n = 4); bypass surgery (NR) |
(NR) | ||||||
Regensteiner 1990, USA [29] | WIQ | Intermittent claudication (n = 26) | 59 (exercise group); 64 (surgery group) 61 (control group) | NR | Baseline, at week 1, 6 and 12 | supervised exercise (n = 10); bypass surgery (n = 7) |
(<0.90, at rest; < 0.85, after exercise) | ||||||
Smith 2007, Australia [18] | SF-36 AUSVIQOL | Intermittent claudication (n = 71) | 72.8 | 68 | Baseline, at month 1 | NR |
(NR) | ||||||
Spertus 2004, USA [30] | WIQ PAQ SF-36 | Peripheral arterial disease (n = 44) | 68 | 55 | Baseline; at week 2 and 8 | Peripheral revascularization |
(NR) | ||||||
Tew 2013c, UK [24] | WIQ | Intermittent claudication | 65 | 81 | Baseline, within days 7 to 10 of first visit | NR |
(n = 37) | ||||||
(≤0.9, at rest) | ||||||
Treat-Johnson 2012, USA [31] | PADQOL POMS SF-36 WIQ | Peripheral arterial disease (n = 295) | 67.9 | 75 | Baseline; follow-up (not specified) | NR |
(NR) |
Participants’ characteristics
Psychometric data
Instrument (number of items) | Domains (number of levels) | Measure: Response options | Scoring | Mode of administration (reported completion time, min) |
---|---|---|---|---|
Generic PROMs | ||||
Vitality (4), physical functioning (10), bodily pain (2), general health perceptions (5), physical role functioning (4), emotional role functioning (3), social role functioning (2), mental health (5) | Likert scale: 2 to 5 | Each dimension is transformed to give a score of 0 to 100. Lower scores indicating greater disability | Self-completed (11 min) | |
Mobility (1), self-care (1), usual activities (1), pain/discomfort (1), and anxiety/depression (1); VAS | Likert scale: 3; VAS | Preference based, values range from 0 indicating death to 1 representing perfect health | Self-completed | |
SF-6D [25] | Physical functioning (1), role limitation (1), social functioning (1), pain (1), mental health (1), and vitality (1) | Likert scale: 4 to 6 | Preference based 0 = dead to 1 = perfect health | Self-completed |
SF-8 (8) [21] | Vitality (1), physical functioning (1), bodily pain (1), general health perceptions (1), physical role functioning (1), emotional role functioning (1), social role functioning (1), mental health (1) | Likert scale: 5 | Each dimension is transformed to give a score of 0–100. Lower scores indicating greater disability | Self-completed (2.5 min) |
NHP (38) [19] | Physical mobility (8), pain (8), sleep (5), energy (3), emotional reactions (9), and social isolation (5) | Dichotomous | 0 (no health problems) to 100 (all the health problems) | Self-completed |
POMS (65) [31] | NR | Likert scale: 5 | NR | Self-completed |
Condition-specific PROMs | ||||
AUSVIQUOL (10) [18] | General health perceptions (3), function, mobility and pain (5), psychosocial aspects (2) | Likert scale: 5 | Reponses are given points from 10 to 0 for each answer, these are summed to give a quality of life score ranging from 0 (poor) to 100 (excellent) | Interviewer or self-completed (3.27 min) |
ICQ (16) [20] | Health related quality of life (16) | Likert scale: 5 | Summing scores and transforming to a 0–100 scale | Self-completed (3.7 min) |
PAQ (20) [30] | Physical limitation (7), symptoms (4), quality of life (3), social function (3), treatment satisfaction (3) | Likert scale: 5 | 0–100 (lower scores indicating worse performance) | Self-completed |
PADQOL (38) [31] | Social relationships and interactions (9), self-concept and feelings (7), symptoms and limitations in physical functioning (8), fear and uncertainty (4), positive adaptation (7) | Likert scale :5 | Summed and transformed score 0 to 100% | Self-completed (5 to10 min) |
SIPic (12) [22] | Sickness related behaviour (12) | Number of items endorsed | 0 (best quality of life) to 12 (worst quality of life) | Self-completed |
Symptom severity (8) Walking distance (7), walking speed (4), stair climbing (3) | Likert scale: 5 | 0 (unable to do) to 4 (no difficulty) | Self-completed (6 min) | |
Pain (4), activity (8), emotional (7), symptoms (4), and social (2) | Likert scale: 7 | 1 (the worst) to7 (the best possible) | Self-completed |
Assessment of psychometric properties
Internal consistency | Test-retest | Content validity | Construct validity | Responsiveness | Floor/ ceiling | Acceptability | |
---|---|---|---|---|---|---|---|
Generic PROMs | |||||||
EQ-5D | |||||||
Chetter 1997 [19] | 0 | ? | 0 | −/+ | −/+ | 0 | 0 |
Chong 2002 [20] | 0 | 0 | 0 | ? | −/+ | 0 | 0 |
Coyne 2003 [26] | 0 | 0 | 0 | −/+ | 0 | 0 | 0 |
Mazari 2010 [25] | 0 | 0 | 0 | + | −/+ | 0 | 0 |
Mehta 2006 [22] | 0 | 0 | 0 | ? | + | 0 | 0 |
NHP | |||||||
Chetter 1997 [19] | 0 | ? | 0 | −/+ | + | −/+ | 0 |
POMS | |||||||
Treat-Jacobson 2012 [31] | 0 | 0 | 0 | −/+ | 0 | 0 | 0 |
SF-6D [25] | 0 | 0 | 0 | −/+ | + | 0. | 0 |
SF-8 | |||||||
Gulati 2009 [21] | 0 | ? | 0 | + | −/+ | 0 | 0 |
SF-36 | |||||||
Chetter 1997 [19] | 0 | ? | 0 | −/+ | −/+ | −/+ | 0 |
Chong 2002 [20] | 0 | 0 | 0 | + | −/+ | 0 | 0 |
Coyne 2003 [26] | 0 | 0 | 0 | −/+ | 0 | 0 | 0 |
Gulati 2009 [21] | 0 | ? | 0 | + | −/+ | 0 | 0 |
Izquierdo-Porrera 2005 [27] | 0 | 0 | 0 | −/+ | 0 | 0 | 0 |
Mazari 2010 [25] | 0 | 0 | 0 | −/+ | + | 0 | 0 |
Mehta 2006 [22] | 0 | 0 | 0 | + | −/+ | 0 | 0 |
Morgan 2001 [23] | 0 | 0 | 0 | + | −/+ | 0 | 0 |
Smith 2007 [18] | − | + | 0 | −/+ | 0 | 0 | ? |
Spertus 2003 [30] | + | + | 0 | + | −/+ | 0 | 0 |
Treat-Jacobson 2012 [31] | 0 | 0 | 0 | −/+ | 0 | 0 | 0 |
Condition-specific PROMs | |||||||
AUSVIQUOL | |||||||
Smith 2007 [18] | + | + | 0 | −/+ | 0 | 0 | ? |
ICQ | |||||||
Chong 2002 [20] | −/+ | + | + | −/+ | + | ? | + |
PADQOL | |||||||
Treat-Jacobson 2012 [31] | + | 0 | + | −/+ | 0 | 0 | 0 |
PAQ | |||||||
Spertus 2003 [30] | + | + | + | + | + | 0 | 0 |
SIPic | |||||||
Mehta 2006 [22] | 0 | 0 | 0 | + | −/+ | 0 | 0 |
WIQ | |||||||
Chong 2002 [20] | 0 | 0 | 0 | −/+ | −/+ | 0 | 0 |
Coyne 2003 [26] | −/+ | −/+ | 0 | + | 0 | 0 | 0 |
Izquierdo-Porrera 2005 [27] | 0 | 0 | 0 | −/+ | 0 | 0 | 0 |
McDermott 1998 [28] | 0 | 0 | 0 | −/+ | 0 | 0 | 0 |
Regensteiner 1990 [29] | 0 | ? | 0 | −/+ | + | 0 | 0 |
Spertus 2003 [30] | −/+ | + | 0 | + | −/+ | 0 | 0 |
Tew 2013 [24] | 0 | 0 | 0 | −/+ | 0 | 0 | + |
Treat-Jacobson 2012 [31] | 0 | 0 | 0 | −/+ | 0 | 0 | 0 |
VascuQoL | |||||||
Mazari 2010 [25] | 0 | 0 | 0 | + | + | 0 | 0 |
Mehta 2006 [22] | 0 | 0 | 0 | + | −/+ | 0 | 0 |
Morgan 2001 [23] | + | + | + | + | + | 0 | 0 |
Psychometric and operational criteria | |||||||
0 | Not reported (no evaluation completed) | ||||||
- | Evidence not in favour | ||||||
−/+ | Weak evidence in favour | ||||||
+ | Evidence in favour | ||||||
? | Methodology questionable | ||||||
N.B. Blank criterion validity excluded from the table. |