Table 2.
Results of the two rounds of the Delphi survey
| Votes for exclusion (rated 1–3) (%) | Votes for inclusion (rated 7–9) (%) | ||||
|---|---|---|---|---|---|
| Outcome | Round 1 | Round 2 | Round 1 | Round 2 | Result |
| Mortality | 4 | 81 | Critical | ||
| Survival | 4 | 80 | Critical | ||
| Blood tests | 15 | 14 | 38 | 28 | No consensus |
| Anemia | 12 | 12 | 40 | 31 | No consensus |
| Serum metal deficiencies | 26 | 30 | 18 | 7 | No consensus |
| Markers of oxidative stress | 26 | 30 | 26 | 9 | No consensus |
| Lipid profile | 13 | 15 | 44 | 35 | No consensus |
| Serum inflammatory markers | 6 | 4 | 60 | 77 | Critical |
| Serum assessment of coagulation | 19 | 20 | 34 | 20 | No consensus |
| Clinical observations | 5 | 6 | 62 | 65 | No consensus |
| Cardiovascular events | 3 | 75 | Critical | ||
| Cardiovascular measurements | 6 | 6 | 57 | 66 | No consensus |
| Ear and labyrinth complications | 47 | 55 | 11 | 5 | No consensus |
| Glycated hemoglobin (HbA1c) | 4 | 81 | Critical | ||
| Serum glucose measurements | 16 | 10 | 48 | 46 | No consensus |
| Markers of insulin metabolism | 24 | 16 | 40 | 32 | No consensus |
| Development of cataract | 37 | 41 | 20 | 8 | No consensus |
| Gastrointestinal symptoms | 28 | 31 | 24 | 13 | No consensus |
| Effectiveness of pain relief | 9 | 7 | 56 | 61 | No consensus |
| Odor | 15 | 13 | 45 | 45 | No consensus |
| Pain | 3 | 72 | Critical | ||
| Biochemical markers of inflammation | 3 | 5 | 66 | 75 | Critical |
| Infection | 1 | 90 | Critical | ||
| Bacterial load | 10 | 7 | 52 | 60 | No consensus |
| Need for antimicrobial treatment | 3 | 82 | Critical | ||
| Osteomyelitis | 0 | 89 | Critical | ||
| Falls | 9 | 10 | 45 | 37 | No consensus |
| Metabolic and nutritional outcome | 11 | 9 | 37 | 33 | No consensus |
| Bone reconstruction | 7 | 5 | 54 | 58 | No consensus |
| Bone resection | 4 | 3 | 67 | 72 | Critical |
| Foot fracture | 4 | 2 | 59 | 69 | No consensus |
| Biochemical markers of wound healing | 9 | 9 | 48 | 50 | No consensus |
| Plantar pressure measurements | 5 | 4 | 59 | 69 | No consensus |
| Cerebrovascular events | 7 | 5 | 56 | 60 | No consensus |
| Measures of psychological morbidity | 4 | 2 | 58 | 67 | No consensus |
| Acute kidney injury | 5 | 8 | 63 | 72 | Critical |
| Respiratory complications | 13 | 13 | 41 | 30 | No consensus |
| Time to healing | 1 | 85 | Critical | ||
| Wound appearance | 5 | 70 | Critical | ||
| Wound healing | 0 | 91 | Critical | ||
| Change in ulcer dimensions | 1 | 79 | Critical | ||
| Genetic markers | 34 | 29 | 18 | 9 | No consensus |
| Failure of healing | 1 | 82 | Critical | ||
| Levels of exudate | 6 | 6 | 57 | 62 | No consensus |
| Degree of granulation tissue | 5 | 5 | 60 | 70 | Critical |
| Clinical improvement | 6 | 70 | Critical | ||
| Diabetes-related foot events | 4 | 79 | Critical | ||
| Ulcer recurrence | 0 | 89 | Critical | ||
| Healed diabetes-related foot ulcer | 1 | 82 | Critical | ||
| New ulceration | 1 | 89 | Critical | ||
| Measures of response to treatment | 4 | 75 | Critical | ||
| Maintenance of wound closure | 1 | 80 | Critical | ||
| Clinical features of chronic limb ischemia | 2 | 87 | Critical | ||
| Measurement of limb perfusion | 1 | 87 | Critical | ||
| Limb salvage | 0 | 94 | Critical | ||
| Revascularization | 1 | 89 | Critical | ||
| Primary patency | 3 | 79 | Critical | ||
| Secondary patency | 3 | 78 | Critical | ||
| Pattern of peripheral arterial disease | 4 | 74 | Critical | ||
| Wound bleeding | 13 | 8 | 44 | 44 | No consensus |
| Foot swelling | 7 | 8 | 51 | 64 | No consensus |
| Weight loss | 16 | 16 | 30 | 20 | No consensus |
| Foot elevation | 15 | 16 | 40 | 39 | No consensus |
| Reduction in cigarette smoking | 11 | 9 | 67 | 70 | Critical |
| Clinical signs of infection | 3 | 88 | Critical | ||
| Sleep disturbance | 9 | 9 | 41 | 48 | No consensus |
| Number of interventions | 5 | 4 | 56 | 54 | No consensus |
| Procedural success | 2 | 74 | Critical | ||
| Failure to complete the full course of treatment | 3 | 4 | 67 | 74 | Critical |
| Surgical intervention was undertaken | 3 | 76 | Critical | ||
| Logistics of delivery of health care | 8 | 5 | 52 | 86 | Critical |
| Patient experience | 1 | 0 | 69 | 82 | Critical |
| Safety | 3 | 78 | Critical | ||
| Tolerability | 3 | 1 | 69 | 86 | Critical |
| Self-reported psychological measures | 5 | 3 | 60 | 74 | Critical |
| Global quality of life | 3 | 1 | 65 | 83 | Critical |
| Health-related quality of life | 1 | 71 | Critical | ||
| Return to normal physical activities | 3 | 75 | Critical | ||
| Ambulatory status | 2 | 76 | Critical | ||
| Measure of foot function | 3 | 1 | 67 | 83 | Critical |
| Offloading | 2 | 80 | Critical | ||
| Role functioning | 2 | 1 | 69 | 83 | Critical |
| Psychological impact on partner | 5 | 6 | 50 | 56 | No consensus |
| Cost | 6 | 3 | 59 | 69 | No consensus |
| Product wastage | 14 | 13 | 40 | 46 | No consensus |
| Length of hospital stay | 3 | 3 | 67 | 67 | No consensus |
| Treatment duration | 3 | 1 | 64 | 78 | Critical |
| Wound care | 2 | 75 | Critical | ||
| Hospital admission | 2 | 79 | Critical | ||
| Major amputation | 2 | 93 | Critical | ||
| Revision amputation | 2 | 89 | Critical | ||
| Need for additional surgical procedures | 2 | 84 | Critical | ||
| Forefoot amputation | 2 | 87 | Critical | ||
| Minor amputation | 2 | 85 | Critical | ||
| Requirement for debridement | 3 | 81 | Critical | ||
| Requirement for social care | 6 | 4 | 58 | 68 | No consensus |
| Complications of revascularization | 2 | 80 | Critical | ||
| Complications of debridement | 2 | 74 | Critical | ||
| Complications of plaster casting | 3 | 3 | 66 | 69 | No consensus |
| Device related complications | 2 | 0 | 64 | 75 | Critical |
| Adverse events | 1 | 79 | Critical | ||
| Serious adverse events | 1 | 89 | Critical | ||
| Pruritus | 21 | 16 | 26 | 18 | No consensus |
Values are presented as a proportion of respondents selecting a specific rating for each outcome given in percentages. Only outcomes without consensus were rescored in the second round. Critical outcomes for potential inclusion in COS are defined as ≥70% of respondents scoring as 7–9 (critical) and 1–3 by ≤15%. Outcomes for exclusion are defined as ≥70% of respondents scoring as 1–3 (not important) and 7–9 by ≤15%. Indeterminate votes (neither for inclusion or exclusion) are not presented in the table.