Table 4.
Frequency of general and disease-specific PROMs in device studies
| Device categories | Frequency of general HRQoL measures (% of total studies/% of studies with PROM) | Frequency of disease-specific PROMs (% of total studies/in % of studies with PROM) | Proportion of general HRQoL measures (to the total number of studies/to studies with PROM) |
|---|---|---|---|
| Absorbable sutures | VAS (2%/17%) | – | NA |
| Bone grafts |
VAS (7%/48%) EQ-5D (3%/21%) SF-36 (2%/12%) SF-12 (2%/12%) |
ODI (1%/9%) |
0.1 0.9 |
| Cardiac pacemakers |
EQ-5D (2%/12%) SF-36 (2%/16%) VAS (1%/10%) |
MLWHF (3%/20%) |
0.06 0,4 |
| Central venous catheters |
SF-36 (1%/20%) VAS (1%/20%) EQ-5D (0.5%/10%) |
QLQC30 (1%/20%) VAD (0.5%/10%) QASICC (0.5%/10%) |
0.3 0.5 |
| Contact lens solutions | VAS (3%/11%) |
CLUE (1%/11%) VFQ25 (1%/11%) |
0.025 0.1 |
| Dental implants | VAS (2.5%/25%) |
OHIP-14 (1%/10%) OHIP-15 (0.5%/5%) OHIP-G-49 (0.5%/5%) |
0.05 0.25 |
| Hip implants | EQ-5D (21%/46%) |
HHS (28%/63%) OHS (18%/40%) WOMAC (7%/15%) HOOS (7%/15%) |
0.2 0.5 |
| Intramedullary nails |
EQ-5D (16%/38%) VAS (8%/19%) |
HHS (8%/19%) DASH (8%/19%) |
0.25 0.6 |
| Intraocular lens |
EQ-5D (1%/6%) VAS (1%/6%) |
VF-14 (2%/15%) VFQ25 (2%/12%) |
0.02 0.1 |
| Orthopedic plates |
EQ-5D (35%/72%) VAS (12%/24%) SF-12 (4%/9%) |
DASH (11%/22%) PRWE (6%/13%) |
0.5 1.1 |
| Peripheral venous catheters |
VAS (3%/67%) NRS (2%/33%) |
– | NA |
| Spinal fusion devices |
VAS (23%/67%) SF-36 (10%/28%) EQ-5D (9%/11%) PSI (4%/6%) |
ODI (21%/31%) |
0.4 1.4 |
In the first column, the general health-related quality-of-life (HRQoL) measures are set out. In the brackets, the first value expressed in percentage indicates the frequency of PROMs in relation to the total number of studies in the concerned device category. The second percentage indicates the frequency of the PROM concerned relative to the number of studies that included PROMs. In the second column, the frequency of disease-specific PROMs is indicated according to the same methodology. The third column indicates the proportion of HRQoL measures relative to the total number of studies (upper value) and to the overall number of studies that included PROMs in the concerned device category. Values close to 0 indicate rare use of general HRQoL measures in the studies, while values close to 1 mean most of the studies included at least one of measure. Values over 1 means that studies included more than one general HRQoL measures in average. The use of general HRQoL measures was the highest in clinical studies of spinal fusion devices, orthopedic plates, and bone grafts, respectively
EQ-5D EuroQol-5-dimensions, VAS visual analogue scale, SF-08/36/12 short form 36/12, MLWHF Minnesota Living with Heart Failure, ODI Oswestry disability index, HHS Harris hip score, OHS Oxford hip score, WOMAC Western Ontario and McMaster universities osteoarthritis index, HOOS hip disability and osteoarthritis outcome score, VFQ-25 visual functioning questionnaire, NRS numeric-rating scale, CLUE contact lens user experience, PSI patient satisfaction index, DASH disabilities of the arm, shoulder and hand, OHIP oral health impact profile, PRWE patient-rated wrist evaluation