Table 12B. GRADE Level of Evidence for Endovascular RFA versus Laser Ablation for Varicose Veins.
| Outcome | Study Design | Quality (Consort) | Consistency Effects | Directness and generalizability | Summary Study Findings | Overall Quality |
|---|---|---|---|---|---|---|
| Pain and Recovery | 2 RCT 1 CCT | High | Consistent reports | Appropriate range of patients, both interventions performed in outpatient setting with local anaesthesia and with recovery to both usual activity and return to work | Pain and bruising was significantly lower after RFA up to 2 weeks but not at one month or when pain was corrected for analgesic use. Recovery was comparable in the two groups. | Moderate |
| Vein occlusion or obliteration | 1 RCT 3 CCT | Low | Inconsistent reporting and variable study designs | RCT involved cases of bilateral VV limiting generalizability and the CCT studies compared ablation techniques under vein restrictions applicable to RFA but not to ELT. | Ablation rates in the RCT and controlled clinical trials resulted in conflicting results | Low |
| Vein Symptom Relief | 2 RCT | High | Consistent reports | Appropriate range patients with reliable and valid assessment but short term evaluation limits interpretation of treatment effectiveness | Vein symptom relief was significantly improved over baseline in both treatment groups but was higher after RFA than ELT at 2 weeks but not at I month. | Moderate |
| HRQOL | 2 RCT | High | Consistent reports | Appropriate range patients with reliable and valid assessment but timing of assessment early post-operatively limits validity | Significant improvement in vein specific QOL were reported in both endovascular groups with no between group differences | Low |
| Recurrence | 1 RCT 3 CCT | Low | Limited and variable reporting | RCT involved cases of bilateral VV limiting generalizability and the CCT studies compared ablation techniques under vein restrictions applicable to RFA but not to ELT. | Ablation rates in the controlled clinical trials resulted in conflicting results | Low |
| Patient satisfaction | NR | NR | NR | NR | NR | NR |
HRQOL; health related quality of life, NR, not reported; RCT; randomized controlled trial