Table 3.
Characteristics of economic studies based on clinical trials
| Reference (Country) | Year of valuation | Intervention | Study design (sample size)a | Wound type | Mean initial ulcer area (cm2) | Mean patient age (years) | Wound healing | Horizon time | ICER/ INHB | Limitations needed improvements |
|---|---|---|---|---|---|---|---|---|---|---|
| Simon et al. (UK) [25] | 1993–1994 | Community leg ulcer clinics vs. traditional care (Stockport district) with Trafford district as contemporary control |
Prospective 3-month longitudinal 1993: 252 1994: 233 |
VLUs DFUs |
NR | NR |
Ulcers healed: 1993: 26 % 1994: 42 % |
3 months extrapolated to 1 year | −£1,186/additional ulcer healed |
No pt/ wound demographics; Sensitivity analysis needed; Subtypes of VLUs/DFUs need to be included |
| Morrell et al. (UK) [26] | 1995 | Leg ulcer clinic (I) vs. home care (C) (district nursing) | RCT (233) | VLU |
I: 16.2 C: 16.9 |
I: 73.8 C: 73.2 |
MHT (weeks): I: 20 C: 43 Proportion of wounds healed at 12 weeks: I: 34 % C: 24 % |
1 year | £2.46/ulcer-free week |
Details on resource utilization and some costs categories missing; Sensitivity analysis should include changes in healing rates |
| Thomson and Brooks (Scotland) [27] | 1995 | Current care vs. addition of PU prevention program (geriatric unit setting) | Prospective cross-sectional/ longitudinal (252 beds) | PUs | NR | NR |
41 % pts have PUs; 42 PUs preventable |
1 year | −£7,717/PU averted |
No pt/wound demographics; study is only a projection of expected cost benefit; Sensitivity analysis needed |
| Ohura et al. (Japan) [28, 29] | 2001–2002 | Modern vs. traditional dressings with and without SWMA | Prospective cohort (83) | PUs (Stage II/III) | NR | NR | Modern dressings + SWMA: PSST reduction: 11.1; traditional dressings, no SWMA: 9.0 | 12 weeks | −$448/ PSST point reduction |
Uncertainty arising from small sample size, summary benefits (units used), and lack of perspective; Sensitivity analysis needed |
| Gordon et al. (Australia) [30] | 2005 | ‘Leg Club Model’ (community nursing care) vs. traditional home community nursing care | RCT (56) | VLU | NR | 68 % ≥71 | NR | 6 months |
At 6 months: $A−693/healed ulcer (provider perspective) $A515/healed ulcer (collective perspective) $A322/pain reduction score (collective perspective) |
Lacks healing rate and pain reduction data; Small sample size, so uncertainty over results; Sensitivity analysis needs to incorporate different healing rates |
| Vu et al. (Australia) [31] | 2000 | Multi-disciplinary wound care vs. usual care | Pseudo-randomized pragmatic cluster (176 residents, 44 high-care nursing homes) | VLUs and PUs | NR |
83.0 (intervention) 83.7 (control) |
MHT: 92.9 days (intervention) 129.4 days (control) |
20 weeks | $A−53.3/ulcer-free week |
Cost reporting/ transparency could be improved; Sensitivity analysis used WTP methodology, but additional results from other methodologies would be useful |
| Harris and Shannon (Canada) [32] | 2005 | Two nursing models: specialty agency (I), and hybrid (specialty + RN/RPN; C) | Retrospective chart audit (361) | DFU, VLU, PU, and other diabetic |
I: 74.2 % <4 cm2 C: 69.8 % <4 cm2 |
I: 68.6 C: 69.8 |
MHT (days): I: 99 C: 143 |
1 year? | $Can−922/ulcer-free week | Unclear time horizon and perspective; missing model structure; other costs besides nursing need to be considered |
| Sanada et al. (Japan) [33] | 2007 | Training for WOCNs/ hospital reimbursement incentive (I) vs. none (C) | Prospective cohort (105; 59 centers) | High-risk PU |
NR Braden score: I: 11.8 C: 12.4 |
NR |
DESIGN score 3 weeks): I: 9.0 C: 13.1 |
1 year | ¥−14,272/unit DESIGN score | Detailed cost considerations missing; no Sensitivity analysis undertaken; benefit unit obscure—addition of other units could improve results |
| Makai et al. (Netherlands) [34] | 2006 | Quality improvement initiative evidence-based prevention | Prospective cohort, pre–post design (88; 25 organizations) | PU | NR | 82 |
Incidence (stage I/II, 1 month): Pre: 15 % Post: 4.5 % Prevalence (all, 12 months) Pre: 38.6 % Post: 22.7 % |
2 years |
Intervention sustained: €78,517/ QALY Intervention partially sustained: €88,692/ QALY Intervention not sustained: €131,253/ QALY |
PSA missing much detail; Markov model lacking pathways (graphic), transition probabilities, and costs for each cycle; some uncertainty over outcomes due to relatively small sample size |
| Shannon et al. (USA) [35] | 2010 | Advanced vs. standard PU prevention protocol | Randomized controlled cohort study (133) | PUs | NR |
I: 75.8 C: 73.2 |
PU incidence: I: 12 % C: 36 % |
1 year | −$3,715/averted PU | Study only applicable to residents at a moderate-to-high risk of developing PU; some outcome uncertainty due to small control sample size |
C control group, DFU diabetic foot ulcer, I intervention group, ICER incremental cost-effectiveness ratio, INHB incremental health benefit, MHT mean time to heal, NR not reported, PSA probability sensitivity analysis, PSST pressure sore status tool, pt(s) patient(s), PU pressure ulcer, QALY quality-adjusted life-year, RCT randomized controlled trial, RN registered nurse, RPN registered practical nurse, SWMA standard wound management algorithm, VLU venous leg ulcer, WOCN wound ostomy continence nurse, WTP willingness to pay, $A Australian dollars
aSample size based on number of pts unless otherwise stated