Introduction
Methods
PRO selection
Variables
Outcomes
Statistical analysis
Ethics and reporting
Results
Participant recruitment and study demographics
Study sample n = 200 | Local population n = 341 | p value | ||
---|---|---|---|---|
Age (years) | Mean (SD) years | 46.2 (14.3) | 49.4 (15.9) | 0.02* |
IQR | 34.6 – 56.8 | 35.4 – 62.0 | ||
Sex | Female | 163 (81.5) | 292 (85.6) | 0.22† |
Male | 37 (18.5) | 49 (14.4) | ||
Charlson comorbidity index score | 0 | 157 (78.5) | 248 (72.7) | 0.05‡ |
1 | 22 (11.0) | 44 (12.9) | ||
2 | 13 (6.5) | 32 (9.4) | ||
≥ 3 | 8 (4.0) | 17 (5.0) | ||
Body mass index (kg/m2) | Median | 29.5 | 29.7 | 0.64* |
IQR | 25.5 – 35.9 | 26.0 – 34.3 | ||
Length of stay | 0 days | 123 (61.5) | 212 (62.2) | 0.18‡ |
1 day | 63 (31.5) | 92 (27.0) | ||
2 days | 6 (3.0) | 8 (2.3) | ||
≥3 days | 8 (4.0) | 29 (8.5) |
30-Day outcomes
Study sample n = 200 | Local population n = 341 | p value | |
---|---|---|---|
Complications | 26 (13.0) | 42 (12.3) | 0.89† |
Intra-abdominal collection | 1 (0.5) | 5 (1.5) | |
Wound infection | 9 (4.5) | 17 (5.0) | |
Other wound problema | 3 (1.5) | 4 (1.2) | |
Post-operative bleed | 1 (0.5) | 0 | |
Suspected chyle leak | 1 (0.5) | 0 | |
Suspected bile leak | 1 (0.5) | 2 (0.6) | |
Small bowel injury | 1 (0.5) | 0 | |
Haemorrhagic pancreatitis | 1 (0.5) | 0 | |
Persistent pain | 5 (2.5) | 10 (2.9) | |
Otherb | 3 (1.5) | 4 (1.2) | |
Return to theatre | 4 (2.0) | 2 (0.6) | 0.20† |
Laparoscopic washout and drain | 4 (2.0) | 2 (0.6) | |
Laparotomy | 2 (1.0) | 2 (1.0) | |
Re-admissions | 7 (3.5) | 13 (3.8) | 1.00† |
Return to theatre | 1 (0.5) | 2 (0.6) | |
Percutaneous drain | 1 (0.5) | 3 (0.9) | |
Intravenous treatment | 4 (2.0) | 7 (2.0) | |
Observation | 1 (0.5) | 1 (0.3) | |
Re-admission length of stay | |||
Mean days (SD) | 1.6 (2.8) | 1.7 (3.2) | 0.94‡ |
Median days (IQR) | 0 (0.0–2.2) | 0 (0.0–3.0) | |
Mortality | 0 | 0 | – |
Patient-reported outcome measures
HRQoL domains | Preoperative n = 200 | 30 days n=61 | 3 months n = 54 | 6 months n = 38 |
---|---|---|---|---|
Physical functioning | 55.4 (21.6) | 17.5 (19.8)* | 18.6 (19.8)* | 16.7 (20.6)* |
Systemic functioning | 61.1 (32.6) | 31.6 (31.9)* | 18.1 (25.4)* | 18.4 (30.0)* |
Emotional functioning | 48.9 (32.3) | 15.6 (25.9)* | 16.7 (28.7) * | 7.9 (20.2)* |
Social functioning | 37.7 (27.9) | 21.8 (22.4)* | 7.9 (14.8)* | 7.9 (12.7)* |
Overall | 75.4 (23.3) | 19.3 (26.0)* | 16.2 (22.9)* | 16.4 (29.2)* |
HRQoL domains | Preoperative n = 200 | 30 days n=61 | 3 months n = 54 | 6 months n = 38 |
---|---|---|---|---|
Physical functioning | 68.6 (28.3) | 75.5 (29.6) | 81.4 (28.9)* | 85.9 (19.3)* |
Role limitations due to physical health | 35.0 (41.4) | 41.4 (43.0) | 69.4 (40.8)* | 78.3 (36.4)* |
Role limitations due to emotional problems | 53.7 (43.0) | 67.8 (42.1) | 80.2 (35.2)* | 71.9 (39.9) |
Energy/fatigue | 36.5 (22.8) | 51.9 (26.1)* | 56.7 (25.4) * | 56.8 (25.8)* |
Emotional well-being | 60.1 (21.5) | 73.7 (22.5)* | 74.3 (21.9)* | 73.5 (21.7) |
Social functioning | 57.1 (28.9) | 73.2 (26.0)* | 78.5 (27.6)* | 83.9 (24.1)* |
Pain | 38.2 (26.1) | 57.5 (26.0)* | 70.6 (29.5)* | 76.9 (27.1)* |
General health | 52.5 (21.1) | 64.7 (25.1)* | 60.6 (26.0) | 63.0 (22.6) |
Change in health | 36.4 (24.4) | 65.2 (28.6)* | 62.5 (29.4)* | 69.1 (29.3)* |
Completion rates
Reliability
30 days versus 3 months | 3 months versus 6 months | |||||
---|---|---|---|---|---|---|
Spearman’s r | 95% CI | p value | Spearman’s r | 95% CI | p value | |
CSQ | ||||||
Physical functioning | 0.35 | 0.03–0.60 | 0.03 | 0.52 | 0.20–0.74 | <0.01 |
Systemic functioning | 0.53 | 0.25–0.72 | <0.01 | 0.59 | 0.29–0.78 | <0.01 |
Emotional functioning | 0.65 | 0.42–0.80 | <0.01 | 0.54 | 0.23–0.75 | <0.01 |
Social functioning | 0.41 | 0.10–0.65 | <0.01 | 0.65 | 0.38–0.82 | <0.01 |
Overall | 0.33 | 0.01–0.59 | 0.04 | 0.86 | 0.72–0.93 | <0.01 |
SF36 | ||||||
Physical functioning | 0.62 | 0.37–0.78 | <0.01 | 0.70 | 0.45–0.80 | <0.01 |
Role limitations due to physical health | 0.47 | 0.18–0.69 | <0.01 | 0.83 | 0.67–0.92 | <0.01 |
Role limitations due to emotional problems | 0.47 | 0.18–0.69 | <0.01 | 0.47 | 0.13–0.71 | <0.01 |
Energy/fatigue | 0.77 | 0.60–0.88 | <0.01 | 0.82 | 0.66–0.91 | <0.01 |
Emotional well-being | 0.75 | 0.56–0.86 | <0.01 | 0.75 | 0.54–0.87 | < 0.01 |
Social functioning | 0.80 | 0.65–0.89 | <0.01 | 0.53 | 0.21–0.74 | <0.01 |
Pain | 0.66 | 0.44–0.81 | <0.01 | 0.79 | 0.60–0.89 | <0.01 |
General health | 0.87 | 0.76–0.93 | <0.01 | 0.70 | 0.46–0.85 | <0.01 |
Change in health | 0.58 | 0.32–0.76 | <0.01 | 0.56 | 0.26–0.77 | <0.01 |
Internal consistency
Number of items | Sum of variances | Variance of total scores | Cronbach’s alpha | |
---|---|---|---|---|
CSQ | ||||
Physical functioning | 6 | 5499.19 | 16,793.75 | 0.81 |
Social functioning | 3 | 3059.44 | 6975.19 | 0.84 |
SF36 | ||||
Physical functioning | 10 | 12,055.31 | 79,873.44 | 0.94 |
Role limitations due to physical health | 4 | 9037.50 | 27,300.00 | 0.89 |
Role limitations due to emotional problems | 3 | 7288.50 | 16,579.00 | 0.84 |
Energy/fatigue | 4 | 2725.11 | 8292.79 | 0.90 |
Emotional well-being | 5 | 3467.29 | 11,537.75 | 0.87 |
Social functioning | 2 | 1883.67 | 3316.11 | 0.86 |
Pain | 2 | 1549.75 | 2716.75 | 0.86 |
General health | 5 | 3989.48 | 11,131.23 | 0.80 |
Floor and ceiling effects
Floor effect % | Ceiling effect % | |
---|---|---|
CSQ | ||
Physical functioning | 0 | 2.0 |
Systemic functioning | 23.5 | 12.0 |
Emotional functioning | 11.0 | 17.5 |
Social functioning | 3.0 | 12.5 |
Overall | 34.0 | 1.0 |
SF36 | ||
Physical functioning | 1.5 | 19.5 |
Role limitations due to physical health | 50.0 | 22.5 |
Role limitations due to emotional problems | 30.5 | 40.5 |
Energy/fatigue | 4.0 | 0.5 |
Emotional well-being | 0.5 | 0.5 |
Social functioning | 2.5 | 15.0 |
Pain | 11.0 | 4.5 |
General health | 0 | 0 |
Change in health | 15.0 | 4.0 |
Responsiveness and effect sizes
HRQoL domains | 30 days n=61 | 3 months n=54 | 6 months n=38 |
---|---|---|---|
CSQ | |||
Physical functioning | 1.8 | 1.7 | 1.8 |
Systemic functioning | 0.9 | 1.3 | 1.3 |
Emotional functioning | 1.0 | 1.0 | 1.3 |
Social functioning | 0.6 | 1.1 | 1.1 |
Overall | 2.4 | 2.5 | 2.5 |
SF36 | |||
Physical functioning | 0.2 | 0.4 | 0.6 |
Role limitations due to physical health | 0.1 | 0.8 | 1.0 |
Role limitations due to emotional problems | 0.3 | 0.6 | 0.4 |
Energy/fatigue | 0.7 | 0.9 | 0.9 |
Emotional well-being | 0.6 | 0.7 | 0.6 |
Social functioning | 0.6 | 0.7 | 0.9 |
Pain | 0.7 | 1.2 | 1.5 |
General health | 0.6 | 0.4 | 0.5 |
Change in health | 1.2 | 1.0 | 1.3 |