Table 1 Study outcomes
Outcomes | Measure or comparison |
|---|---|
Primary outcome | |
Diagnostic performance for melanoma | Number of unnecessary excisions or biopsies (i.e. false positives). An unnecessary biopsy is one performed due to clinical suspicion of melanoma, where the histopathology is benign |
Secondary outcomes | |
Additional diagnostic performance outcomes for melanoma | NNB to detect one melanoma, benign:malignant ratio Number of false negatives (determined by follow-up) and the morbidity and complications from procedures |
Diagnostic performance outcomes for melanoma and other skin cancers combined | Benign to malignant ratio and the NNB |
Quality of life | Patient quality of life outcomes—AQOL-8D |
Patient anxiety and acceptability | EORTC QLQ-C30, FCR4 and a purpose-designed patient acceptability scale |
Health economic outcomes | |
- Health system resource utilisation and out-of-pocket costs - Health-related QOL using a preference-based multi-attribute utility instrument - Cost-effectiveness of the intervention compared with control (usual care) - Budget impact analysis | Number of clinic visits, personnel time, procedures, diagnostic tests, hospitalisations, overhead costs (e.g. IT, data transfer systems), capital equipment, consumables and patient out-of-pocket payments documented from Medicare claims AQOL-8D utilities for calculation of QALYs Incremental cost-effectiveness ratios or incremental net benefit for both cost per unnecessary excision or biopsy avoided and cost per QALY gained of MSP compared with usual care Budget impact of the intervention to Australian Medicare |