Of the 685 participants who completed the EQ5D-5L at baseline, 526 (77%) completed a follow-up EQ5D-5L at PIVC removal. The FACIT-TS-G was provided as a supplementary instrument to 264 participants (50%), with the remining 262 participants completing the AHPEQS instrument. Most participants were male (67%), with a mean age of 62 (SD 15.7) years (Table 1). A large majority of participants (95%) were admitted for emergent- or planned- surgery, and were from a single large tertiary hospital (94%); this was representative of the patients in the larger multi-centre RCT sample (17). Devices were commonly 22–24 gauge/size (76%), inserted in the forearm (71%). Patient and device characteristics were similar between the FACIT-TS-G and AHPEQS groups; there were no AHPEQS instruments completed at site two (small tertiary hospital). Overall, 20% (103/524) of participants completing follow-up instruments had experienced two or more PIVC insertion attempts; 30% (155/524) experienced all-cause PIVC failure, with phlebitis the most reported complication (n = 73, 14%).
At baseline, more than half of participants reported (in relation to their PIVC) either ‘no’ or ‘slight’ problems on the EQ5D-5L, with mobility, personal-care, pain/discomfort, or anxiety/depression (68%, 74%, 52%, and 80%, respectively), whilst slightly less than half reported ‘no’ or ‘slight’ problems for usual activities (48%) (Table 2). This was consistent at follow up with more than half of participants reporting either no or slight problems with mobility, personal-care, pain/discomfort, or anxiety/depression (67%, 73%, 61%, and 82%, respectively), and 49% for usual activities. The self-reported overall health score was 61.4 (SD 22.9) and 64.7 (SD 21.3) at baseline and follow-up, respectively (Fig. 1). The mean EQ5D-5L utility score was 0.52 (95% confidence interval [CI] 0.49–0.55) and 0.55 (95% CI 0.52–0.58) at baseline and follow-up, respectively (Fig. 1).
Participants completing the FACIT-TS-G instrument demonstrated poorer outcomes/experiences in their responses, compared to that which they reported for the EQ5D-5L. Compared to what was expected, participants rated the effectiveness and side effects (of their PIVC) as a little/a lot better in 56% and 44% of responses, respectively. Participants most frequently answered “completely agree” that they received assistance in evaluating the effects of their treatment, received treatment that were right for them, and were satisfied with the effects of treatment (49%, 66% and 57%, respectively). Among participants, 84% would recommend this treatment to others and 82% would choose it again. Overall care was reported as very good or excellent among 67% of respondents.
Responses to the AHPEQS instrument (regarding the overall hospital episode) demonstrated positive experiences, with participants responding that they ‘always’ or ‘mostly’ had their views and concerns listened to (89%), had their individual needs met (91%), felt cared for (97%), were involved in decision-making (82%), were kept informed (87%), believed their staff communications with each other (90%), received adequate pain relief (91%), and felt confident in their safety of care (97%). Overall quality of treatment was reported as ‘very good’ or ‘good’ for 97% of all respondents. Despite this, 19% of participants reported unintentional harm because of their care, including emotional distress, physical harm, or both.
Table 2
Responses EQ5D-5L, FACIT-TS-G, AHPEQS
Instrument
|
Scale
|
|
EQ5D
|
No
|
Slight
|
Moderate
|
Severe
|
Extreme
|
Score
|
T0 (n = 685)
|
|
|
|
|
|
61.4 (SD 22.9)
|
Mobility
|
343 (50)
|
125 (18)
|
80 (12)
|
46 (7)
|
91 (13)
|
|
Personal care
|
364 (53)
|
146 (21)
|
79 (12)
|
45 (7)
|
51 (7)
|
|
Usual activities
|
209 (31)
|
122 (18)
|
105 (15)
|
40 (6)
|
209 (31)
|
|
Pain/discomfort
|
236 (34)
|
117 (17)
|
199 (29)
|
103 (15)
|
30 (4)
|
|
Anxiety/depression
|
440 (64)
|
105 (15)
|
111 (16)
|
21 (3)
|
8 (1)
|
|
T1 (n = 526)
|
|
|
|
|
|
64.7 (SD 21.3)
|
Mobility
|
256 (49)
|
97 (18)
|
77 (15)
|
35 (7)
|
61 (12)
|
|
Personal care
|
284 (54)
|
100 (19)
|
70 (13)
|
36 (7)
|
36 (7)
|
|
Usual activities
|
160 (30)
|
99 (19)
|
92 (17)
|
40 (8)
|
135 (26)
|
|
Pain/discomfort
|
209 (40)
|
113 (21)
|
125 (24)
|
56 (11)
|
23 (4)
|
|
Anxiety/depression
|
330 (63)
|
103 (20)
|
75 (14)
|
7 (1)
|
11 (2)
|
|
AHPEQS (n = 262)
|
Always
|
Mostly
|
Sometimes
|
Rarely
|
Never
|
Didn’t apply
|
Views and concerns
|
156 (60)
|
77 (29)
|
25 (10)
|
2 (1)
|
1 (< 1)
|
1 (< 1)
|
Individual needs
|
168 (64)
|
71 (27)
|
19 (7)
|
4 (2)
|
0 (0)
|
0 (0)
|
Staff explanation (n = 23)
|
5 (22)
|
7 (30)
|
7 (30)
|
4 (17)
|
0 (0)
|
0 (0)
|
Cared for
|
207 (79)
|
48 (18)
|
7 (3)
|
0 (0)
|
0 (0)
|
0 (0)
|
Decision making
|
152 (58)
|
64 (24)
|
32 (12)
|
11 (4)
|
3 (1)
|
0 (0)
|
Informed
|
164 (63)
|
65 (25)
|
22 (8)
|
11 (4)
|
0 (0)
|
0 (0)
|
Inter-staff communication
|
196 (75)
|
39 (15)
|
23 (9)
|
4 (2)
|
0 (0)
|
0 (0)
|
Pain relief
|
198 (76)
|
40 (15)
|
8 (3)
|
2 (1)
|
14 (5)
|
0 (0)
|
Confidence in safety (n = 261)
|
219 (84)
|
33 (13)
|
8 (3)
|
1 (< 1)
|
0 (0)
|
0 (0)
|
|
Physical harm
|
Emotional distress
|
Both
|
No
|
Unexpected harm
|
9 (3)
|
22 (8)
|
19 (7)
|
212 (81)
|
|
Yes
|
No
|
Not sure
|
Didn’t discuss
|
Harm discussed (n = 50)
|
34 (69)
|
15 (30)
|
0 (0)
|
1 (< 1)
|
|
Very good
|
Good
|
Average
|
Poor
|
Very poor
|
Overall quality (n = 261)
|
209 (80)
|
43 (16)
|
8 (3)
|
1 (< 0)
|
0 (0)
|
FACIT-TS-G (n = 264)
|
Lot worse
|
Little worse
|
About the same
|
Little better
|
Lot better
|
Effectiveness
|
9 (3)
|
10 (4)
|
96 (36)
|
61 (23)
|
88 (33)
|
Side effects
|
8 (3)
|
20 (8)
|
120 (45)
|
39 (15)
|
77 (29)
|
|
No
|
Some extent
|
Most part
|
Completely
|
Doctor(s) help
|
23 (9)
|
40 (15)
|
71 (27)
|
130 (49)
|
Right for you
|
4 (2)
|
16 (6)
|
69 (26)
|
175 (66)
|
Satisfied
|
13 (5)
|
24 (9)
|
77 (29)
|
150 (57)
|
|
No
|
Maybe
|
Yes
|
Recommend
|
14 (5)
|
28 (11)
|
222 (84)
|
Choose again
|
13 (5)
|
35 (13)
|
216 (82)
|
|
Poor
|
Fair
|
Good
|
Very good
|
Excellent
|
Overall rating
|
7 (3)
|
15 (6)
|
66 (25)
|
106 (40)
|
70 (27)
|
EuroQual Five Dimension, Five Level = EQ5D-5L; T0 = baseline timepoint; T1 = follow-up timepoint; Australian Hospital Patient Experience Question Set = AHPEQS; Functional Assessment of Chronic Illness Therapy – Treatment Satisfaction – General measure = FACIT-TS-G; SD = standard deviation.
All-cause PIVC failure and multiple insertion attempts were associated with several individual items in the three instruments (EQ5D-5L, FACIT-TS-G, AHPEQS) (presented as co-efficients and p-values in text) (Table 3). For those with all-cause failure, participants were more likely to report increased mobility problems within the EQ5D-5L (utility − 0.02, p = 0.038; disutility 0.02, p = 0.040; ‘slight problems’ 0.08, p < 0.01; ‘moderate problems’ 0.64 p = 0.035; and ‘unable to mobilise’ 0.71 p = 0.033) (detailed EQ5D-5L analysis results available in Supplementary Table 1). In the ordered logistic regression only, all-cause failure statistically significantly correlated with increased problems with ‘usual activities’ (0.37, p = 0.042). Multiple insertion attempts were not associated with any EQ5D-5L items.
With respect to items in the FACIT-TS-G, all-cause PIVC failure was statistically significantly associated with lower effectiveness (-0.56, p < 0.01), satisfaction (-0.47, p < 0.01), likelihood to recommend PIVC to others (-0.17, p = 0.015), likelihood to choose PIVC again (-0.23, p < 0.01), and overall rating (-0.39, p < 0.01) (detailed FACIT-TS-G analysis results available in Supplementary Table 2). Additionally, all-cause failure was significantly associated with a reduced likelihood of participants reporting that doctors didn’t help them (“at all”) evaluate the effects of their PIVC (i.e., increased likelihood of reporting doctors helping them) (-1.89, p = 0.015). Participants with multiple PIVC insertion attempts were statistically significantly more likely to report lower satisfaction “to some extent” with their PIVC (1.79, p < 0.01).
All-cause PIVC failure was statistically significantly associated with participants experiencing unexpected ‘physical and emotional harm’ (1.58, p < 0.01) in the AHPEQS (detailed AHPEQS analysis results available in Supplementary Table 3). Additionally, all-cause failure was statistically significantly associated with participants reporting higher involvement in ‘decision-making’ (0.58, p = 0.049) and greater ‘inter-staff communication’ (0.21, p = 0.046). Multiple PIVC insertion attempts were not associated with any AHPEQS items.
Table 3
Discrimination EQ5D-5L, FACIT-TS-G, AHPEQS
Instrument
|
All-cause device failure
|
Multiple insertion attempts
|
|
Reg
|
Ologit
|
Mlogit*
|
Reg
|
Ologit
|
Mlogit
|
EQ5D T1 (n = 526)
|
|
Utility score (overall)
|
^
|
|
^
|
|
Disutility score (overall)
|
|
|
Mobility (Ref: no)
|
0.33**
|
0.53***
|
Sl: 0.80***
M: 0.64**
U: 0.71**
|
^
|
^
|
^
|
Utility
|
-0.02**
|
|
|
^
|
|
|
Disutility
|
|
|
|
|
|
|
Personal care (Ref: no)
|
^
|
^
|
^
|
^
|
^
|
^
|
Utility
|
^
|
|
|
^
|
|
|
Disutility
|
|
|
|
|
|
|
Usual activities (Ref: no)
|
^
|
0.37**
|
^
|
^
|
^
|
^
|
Utility
|
^
|
|
|
^
|
|
|
Disutility
|
|
|
|
|
|
|
Pain/discomfort (Ref: no)
|
^
|
^
|
^
|
^
|
^
|
^
|
Utility
|
^
|
|
|
^
|
|
|
Disutility
|
|
|
|
|
|
|
Anxiety/depression (Ref: no)
|
^
|
^
|
^
|
^
|
^
|
^
|
Utility
|
^
|
|
|
^
|
|
|
Disutility
|
|
|
|
|
|
|
FACIT-TS-G (n = 264)
|
|
|
|
|
|
|
Effectiveness (Ref: same)
|
-0.56***
|
-0.99***
|
LoW: 2.96***
|
^
|
^
|
^
|
Side Effects (Ref: same)
|
^
|
^
|
^
|
^
|
^
|
^
|
Doctor(s) help (Ref: completely)
|
^
|
^
|
N: -1.89**
|
^
|
^
|
^
|
Right for you
|
^
|
^
|
^
|
^
|
^
|
^
|
Satisfied (Ref: completely)
|
-0.47***
|
-1.01***
|
N: 2.63***
|
^
|
-0.59*
|
SE: 1.79***
|
Recommend (Ref: yes)
|
-0.17**
|
-0.91**
|
No: 1.52**
|
^
|
^
|
^
|
Choose again (Ref: yes)
|
-0.23***
|
-0.93**
|
No: 2.61***
|
^
|
^
|
^
|
Overall rating
|
-0.39***
|
-0.68***
|
^
|
^
|
^
|
^
|
AHPEQS (n = 261)
|
|
|
|
|
|
|
Views and concerns
|
^
|
^
|
^
|
^
|
^
|
^
|
Individual needs
|
^
|
^
|
^
|
^
|
^
|
^
|
Staff explanation (n = 23)
|
^
|
^
|
NA
|
^
|
^
|
NA
|
Cared for
|
^
|
^
|
^
|
^
|
^
|
^
|
Decision making (Ref: always)
|
^
|
0.58**
|
ST: 1.10**
|
^
|
^
|
^
|
Informed
|
^
|
^
|
NA
|
^
|
^
|
NA
|
Inter-staff comm. (Ref: always)
|
0.21**
|
^
|
^
|
^
|
^
|
^
|
Pain relief
|
^
|
^
|
^
|
^
|
^
|
^
|
Confidence in safety
|
^
|
^
|
^
|
^
|
^
|
^
|
Unexpected harm (Ref: no)
|
^
|
^
|
P&E H: 1.58***
|
^
|
^
|
^
|
Harm discussed (n = 50)
|
^*
|
|
|
^*
|
|
|
Overall quality
|
^
|
|
|
|
^
|
|
|
^not significant; *logistic regression; ** p<0.05; *** p<0.01; EuroQual Five Dimension, Five Level = EQ5D-5L; T1 = follow-up timepoint; Functional Assessment of Chronic Illness Therapy – Treatment Satisfaction – General measure = FACIT-TS-G; Australian Hospital Patient Experience Question Set = AHPEQS; reg = regression analysis ; Ologit = ordered logistic regression analysis ; Mlogit = multinomial logit model; ; Ref = reference; comm = communication; NA = not analysable (after 5000 iterations); Sl = slight problems; M = moderate problems; No = No; N = not at all; SE = to some extent; LW = a little worse; LoW = a lot worse; ST = Sometimes; P&E H = Physical and Emotional Harm.
Two FACIT-TS-G items (“would you recommend this treatment to others?” 84% and “would you choose this treatment again?” 82%), and one AHPEQS item (“I felt confident in the safety of my treatment and care” 84%) demonstrated ceiling effect (Table 2). There were no ceiling or floor effects associated with any of the EQ5D-5L items.
The EQ5D-5L responsiveness ES was deemed trivial at 0.16 and 0.15 for all-cause PIVC failure and multiple attempts at PIVC insertion, respectively. The responsiveness statistic demonstrated similar results at 0.16 for both outcomes of interest; the EQ5D-5L SRM overall was 0.15712.