Background
Methods
Intervention description
Costs analysis
Perspective | Variables | Unitary cost (UC) | Monitoringc | Cost per patient modeld |
---|---|---|---|---|
Public Health Systema | Physician labor costs | €0.54/min | CM | NVH x PTH x UC |
RM | NRT x PTR x UC | |||
Administrative labor costs | €0.27/min | CM | NVH x ATH x UC | |
RM | NTH x ATR x UC | |||
Consultation-room | €0.029/min | CM | NVH x PTH x UC | |
RM | ||||
Ambulance | €1.13/km | CM | NVHA x UC | |
RM | ||||
Patients and relativesb | Transportation (round trip) | Taxi (ranged from €14.50 to €142.10); Bus (ranged from €2.60 to €7.43); Private car (€0.19/km) | CM | (NVH – NVHA) x UCIT |
RM | ||||
Lost income costs for hospital visits [20] | €5.05/h of home help service | CM | NVH x TVH x UC | |
RM |
Cost-utility analysis
Primary model robustness analysis
Variablea | Monitoring | Intervention groups [n (CM) = 34; n (RM) = 21] | Monte-Carlo simulation [n (CM) = 5000; n (RM) = 5000] | Assumed distribution | ||||
---|---|---|---|---|---|---|---|---|
Mean | Std.Dev. | Interval | Mean | Std.Dev. | Interval | |||
NVH | CM | 7.49 | 1.70 | (4–12) | 9.40 | 7.24 | (2–88) | Gamma |
RM | 4.38 | 2.62 | (2–10) | 6.38 | 37.34 | (2–30) | Gamma | |
NRT | CM | . | . | . | . | . | . | . |
RM | 6.62 | 1.72 | (4–9) | 8.64 | 6.41 | (2–48) | Gamma | |
NVHA | CM | 1.91 | 0.70 | (1–3) | 1.90 | 1.80 | (0–16) | Gamma |
RM | 1.33 | 0.66 | (0–3) | 1.31 | 1.24 | (0–10) | Gamma | |
UCIT | CM | 8.72 | 9.31 | (2.7–40.27) | 8.69 | 3.18 | (1.28–22.88) | Gamma |
RM | 7.57 | 7.71 | (2.7–34.56) | 7.58 | 1.44 | (3.55–13.36) | Gamma | |
TVH | CM | 75.43 | 39.43 | (0–180) | 74.80 | 63.83 | (0.33–495.32) | Gamma |
RM | 88.57 | 44.98 | (0–180) | 88.56 | 76.33 | (0.04–645.03) | Gamma | |
EQ–5D M12 | CM | 0.82 | 0.37 | (−0.654–1) | 0.81 | 0.73 | (0–6.59) | Gamma |
RM | 0.90 | 0.19 | (0.362–1) | 0.93 | 0.90 | (0–7.65) | Gamma | |
EQ–5D M60 | CM | 0.77 | 0.36 | (−0.572–1) | 0.75 | 0.66 | (0–5.62) | Gamma |
RM | 0.68 | 0.39 | (−0.33–1) | 0.69 | 0.55 | (0–4.28) | Gamma |
Statistical analysis
Results
Patient baseline characteristics
All | RM group (n = 21) | CM group (n = 34) | p-value | |
---|---|---|---|---|
Age (mean) ± SD | 81.00 ± 6.47 | 81.14 ± 7.30 | 80.91 ± 6.01 | 0.690 |
Women (%) | 17 (30.91) | 8 (38.10) | 9 (26.47) | 0.365 |
Attrition (a) | 28 (34.14) | 9 (27.58) | 18 (33.96) | 0.481 |
Pacing indication (%)(b) | ||||
Sinus node disease | 11 (20.00) | 3 (14.29) | 8 (23.53) | 0.493 |
Atrioventricular block | 39 (70.91) | 15 (71.43) | 24 (70.59) | |
Others | 5 (9.09) | 3 (14.29) | 2 (5.88) | |
Disease manifestations (%)(b) | ||||
Syncope | 33 (60.00) | 13 (61.90) | 20 (58.82) | 0.681 |
Dizziness | 16 (29.09) | 7 (33.33) | 9 (26.47) | |
Dyspnoea | 3 (5.45) | 0 (0) | 3 (8.82) | |
Angina | 3 (5.45) | 1 (4.76) | 2 (5.88) |
Attrition
Costs analysis
Perspectives | Variables | All | CM group | RM group | CM vs. RM Difference per patient | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
(n = 55) | (n = 34) | (n = 21) | ||||||||||
Mean | SD | 95% CI | Mean | SD | 95% CI | Mean | SD | 95% CI | Mean dif. | p-value | ||
In-office visits per patient | 6.27 | 2.56 | (5.58–6.97) | 7.44 | 1.71 | (6.84–8.04) | 4.38 | 2.62 | (3.19–5.57) | 3.06 | < 0.001 | |
Transmissions from home per patient | – | – | – | – | – | – | 6.62 | 1.72 | (5.84–7.4) | – | – | |
Public Health System | Physician (€) | 157.50 | 46.80 | (144.85–170.15) | 164.72 | 37.83 | (151.52–177.92) | 145.82 | 57.62 | (119.59–172.05) | 18.90 | 0.191 |
Administrative (€) | 11.82 | 3.29 | (10.93–12.71) | 11.67 | 2.68 | (10.74–12.61) | 12.06 | 4.15 | (10.18–13.95) | −0.39 | 0.703 | |
Staff costs (Physician + Administrative) (€) | 169.32 | 49.97 | (155.81–182.83) | 176.39 | 40.51 | (162.26–190.53) | 157.88 | 61.75 | (129.77–185.99) | 18.51 | 0.231 | |
Transport in ambulance (€) | 63.99 | 55.35 | (49.03–78.96) | 70.11 | 63.42 | (47.98–92.24) | 54.09 | 38.33 | (36.64–71.54) | 16.01 | 0.248 | |
Consultation room (€) | 5.75 | 2.54 | (5.07–6.44) | 7.14 | 1.64 | (6.57–7.71) | 3.50 | 2.09 | (2.55–4.46) | 3.64 | < 0.001 | |
Total PHS costs (€) | 239.07 | 94.79 | (213.44–264.69) | 253.64 | 95.86 | (220.19–287.08) | 215.48 | 90.28 | (174.38–256.57) | 38.16 | 0.144 | |
Patients and relatives | Distance home/hospital (one way kms) | 16.25 | 11.50 | (13.15–19.36) | 15.71 | 11.71 | (11.62–19.79) | 17.14 | 11.37 | (11.97–22.32) | −1.44 | 0.657 |
Informal transport (€) | 32.75 | 39.81 | (21.99–43.52) | 42.42 | 46.99 | (26.02–58.81) | 17.11 | 14.81 | (10.37–23.85) | 25.31 | 0.006 | |
Lost income (€) | 53.45 | 35.43 | (43.88–63.03) | 60.57 | 34.45 | (48.55–72.59) | 41.94 | 34.73 | (26.13–57.75) | 18.63 | 0.059 | |
Total patients’ costs (€) | 86.21 | 57.16 | (70.76–101.66) | 102.98 | 58.77 | (82.48–123.49) | 59.05 | 43.24 | (39.36–78.73) | 43.93 | 0.002 | |
Total Costs | 325.28 | 142.91 | (286.64–363.91) | 356.62 | 144.12 | (306.34–406.91) | 274.52 | 128.45 | (216.06–332.99) | 82.10 | 0.033 |
Public health system perspective
Patients’ perspective
Cost-utility analysis
Variables | All | Conventional Monitoring group | Remote Monitoring group | Difference per patient | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
n | Mean | SD | n | Mean | SD | n | Mean | SD | Mean dif. | p-value | |
EQ5 DM00 | 55 | 0.71 | 0.36 | 34 | 0.72 | 0.36 | 21 | 0.70 | 0.38 | 0.02 | 0.795 |
EQ5 DM12 | 55 | 0.85 | 0.32 | 34 | 0.82 | 0.37 | 21 | 0.90 | 0.19 | −0.08 | 0.301 |
EQ5 DM60 | 55 | 0.73 | 0.37 | 34 | 0.77 | 0.36 | 21 | 0.68 | 0.39 | 0.09 | 0.363 |
QALYM60 | 55 | 3.48 | 1.47 | 34 | 3.58 | 1.45 | 21 | 3.31 | 1.52 | 0.27 | 0.515 |
Cost/QALYM60 (€) | 55 | 195.64 | 515.73 | 34 | 177.08 | 357.90 | 21 | 225.69 | 710.80 | −48.61 | 0.773 |
Cost/patient (€) | 55 | 325.28 | 142.91 | 34 | 356.62 | 144.12 | 21 | 274.53 | 128.45 | 82.10 | 0.033 |
ICER | – | – | – | – | – | – | – | – | – | 301.16 | – |
Primary model robustness analysis
Perspectives | Variables | All | CM group | RM group | CM vs. RM Difference per patient | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
(n = 10,000) | (n = 5000) | (n = 5000) | ||||||||||
Mean | SD | 95% CI | Mean | SD | 95% CI | Mean | SD | 95% CI | Mean dif. | p-value | ||
Public Health System | Physician (€) | 206.44 | 130.58 | (203.88–209) | 207.96 | 160.31 | (203.52–212.41) | 204.92 | 91.68 | (202.37–207.46) | 3.05 | 0.244 |
Administrative (€) | 15.76 | 9.67 | (15.57–15.95) | 14.74 | 11.36 | (14.42–15.05) | 16.78 | 7.47 | (16.57–16.99) | −2.04 | < 0.001 | |
Staff costs (Physician + Administrative) (€) | 222.20 | 140.13 | (219.45–224.95) | 222.70 | 171.67 | (217.94–227.46) | 221.70 | 99.03 | (218.95–224.44) | 1.00 | 0.720 | |
Transport in ambulance (€) | 65.90 | 88.92 | (64.16–67.64) | 70.24 | 88.88 | (67.77–72.7) | 61.56 | 88.75 | (59.1–64.02) | 1.78 | < 0.001 | |
Consultation room (€) | 7.06 | 5.67 | (6.95–7.17) | 9.02 | 6.95 | (8.82–9.21) | 5.10 | 2.87 | (5.02–5.18) | 3.91 | < 0.001 | |
Total PHS costs (€) | 295.16 | 171.38 | (291.8–298.52) | 301.95 | 201.34 | (296.37–307.53) | 288.36 | 134.59 | (284.63–292.09) | 13.59 | < 0.001 | |
Patients and relatives | Informal transport (€) | 47.86 | 54.14 | (46.8–48.92) | 60.64 | 69.11 | (58.72–62.55) | 35.08 | 27.56 | (34.31–35.84) | 25.56 | < 0.001 |
Lost income (€) | 68.74 | 88.61 | (67.01–70.48) | 76.01 | 103.28 | (73.14–78.87) | 61.48 | 70.25 | (59.53–63.43) | 14.53 | < 0.001 | |
Total patients’ costs (€) | 116.60 | 125.85 | (114.13–119.07) | 136.64 | 153.12 | (132.4–140.89) | 96.56 | 86.20 | (94.17–98.95) | 40.09 | < 0.001 | |
Total Costs | 411.76 | 266.17 | (406.54–416.97) | 438.60 | 324.29 | (429.6–447.59) | 384.92 | 187.35 | (379.72–390.11) | 53.68 | < 0.001 |
Variables | All | Conventional Monitoring (CM) group | Remote Monitoring (RM) group | Difference per patient | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
(n = 10,000) | (n = 5000) | (n = 5000) | |||||||||
n | Mean | SD | n | Mean | SD | n | Mean | SD | Mean dif. | p-value | |
EQ5 DM12 | 10,000 | 0.87 | 0.82 | 5000 | 0.81 | 0.73 | 5000 | 0.93 | 0.90 | −0.12 | < 0.001 |
EQ5 DM60 | 10,000 | 0.72 | 0.61 | 5000 | 0.74 | 0.66 | 5000 | 0.69 | 0.55 | 0.06 | < 0.001 |
QALYM60 | 10,000 | 3.43 | 2.34 | 5000 | 3.48 | 2.48 | 5000 | 3.38 | 2.19 | 0.10 | 0.022 |
Cost/QalyM60 (€) | 10,000 | 215.58 | 543.95 | 5000 | 238.73 | 721.12 | 5000 | 192.43 | 265.94 | 46.30 | < 0.001 |
Cost/patient (€) | 10,000 | 5000 | 438.60 | 324.29 | 5000 | 384.92 | 187.35 | 53.68 | < 0.001 | ||
ICER | – | – | – | – | – | – | – | – | – | 501.48 | – |