Optimal Management of Asymptomatic Carotid Artery Stenosis: A Systematic Review and Network Meta-Analysis.

OBJECTIVE: Management of asymptomatic carotid artery stenosis (ACAS), including carotid endarterectomy (CEA), carotid artery stenting (CAS), and best medical treatment (BMT), remains inconsistent in current practice. Early studies reported a benefit of CEA vs. BMT; however, the current risk-benefit profile of invasive therapy lacks consensus. By evaluating the effects of modern BMT vs. invasive intervention on patient outcomes, this study aimed to influence the future management of ACAS. METHODS: A systematic review and series of network meta-analyses were performed assessing peri-operative (within 30 days) and long term (30 days - 5 years) stroke and mortality risk between ACAS interventions. Total stroke, major, minor, ipsilateral, and contralateral stroke subtypes were assessed independently. Traditional (pre-2000) and modern (post-2000) BMT were compared to assess clinical improvements in medical therapy over the previous two decades. Risks of myocardial infarction (MI) and cranial nerve injury (CNI) were also assessed. RESULTS: Seventeen reports of 14 310 patients with > 50% ACAS were included. CEA reduced the odds of a peri-operative stroke event occurring vs. CAS (odds ratio [OR] 1.6, 95% confidence interval [CI] 1.1 - 2.2 [0 - 20 fewer/1 000]). CEA and CAS reduced the long term odds of minor strokes (OR 0.35, 95% CI 0.21 - 0.59 [20 fewer/1 000]) and ipsilateral strokes (OR 0.27, 95% CI 0.19 - 0.39 [30 fewer/1 000]) vs. all BMT. CEA reduced the odds of major strokes and combined stroke and mortality vs. traditional BMT; however, no difference was found between CEA and modern BMT. CAS reduced the odds of peri-operative MI (OR 0.49, 95% CI 0. 26 - 0.91) and CNI (OR 0.07, 95% CI 0.01 - 0.42) vs. CEA. CONCLUSION: Modern BMT demonstrates similar reductions in major stroke, combined stroke, and mortality to CEA. The overall risk reductions are low and data were unavailable to assess subgroups which may benefit from intervention. However, BMT carries the potential to reduce the requirement for surgical intervention in patients with ACAS.

Outcomes of Saphenous Vein Intervention in the Management of Superficial Venous Incompetence: A Systematic Review and Network Meta-analysis.

OBJECTIVE: To determine the most effective modality of intervention to treat saphenous vein insufficiency. SUMMARY OF BACKGROUND DATA: Endovenous therapies have instigated a paradigm shift in the management of superficial venous incompetence. When compared with open surgery, endovenous interventions (foam sclerotherapy, radiofrequency ablation, endovenous laser ablation (EVLA), mechanochemical ablation, and CAE closure) potentially offer reduced morbidity with similar procedural efficacy. METHODS: A systematic review and series of network meta-analyses of randomized controlled trials were performed assessing risks of procedural failure (within 6-weeks) and recurrence (6-weeks to 5-years), defined by ultrasound, between the different modalities of intervention for superficial venous incompetence. Treatment comparisons addressing risks of common adverse events, venous clinical severity score, and pain were also performed. RESULTS: A systematic search identified 51 articles, describing 36 randomized controlled trials, incorporating 7576 limbs. Outcome data on 10 modalities of intervention were analyzed up to 5-year follow-up. CAE resulted in the lowest risk of procedural failure within 6-weeks. Foam sclerotherapy had the highest risk of recurrence while high ligation with stripping (HLS) and Conservatrice Hemodynamique de l'Insuffisance Veineuse en Ambulatoire were ranked best to reduce long-term recurrence. No intervention increased risks of venous thromboembolism and there was minimal difference in morbidity between treatments. All interventions improved venous clinical severity score (range -1.02 to -4.95), however, radiofrequency ablation demonstrated the greatest improvement, followed by EVLA and HLS between 2 to 5-years. EVLA was associated with the highest risk of pain, while mechanochemical ablation offered the least. CONCLUSIONS: Although CAE offered the lowest risk of initial procedural failure, HLS resulted in lower rates of long-term recurrence without considerably increasing morbidity when compared with other endovenous options.

General data protection regulations (2018) and clinical research: perspectives of patients and doctors in an Irish university teaching hospital.

BACKGROUND: Europe's General Data Protection Regulation, or GDPR, is a set of data protection rules on the acquisition, storage, use, and access of personal data. GDPR came into effect in May 2018 when it was introduced across all 27 European Union (EU) member states and the European Economic Area (EEA). Maintaining compliance with this legislation has presented significant new challenges for ongoing clinical research. AIMS: To evaluate the knowledge and expectations of patients and doctors regarding GDPR and implications for future clinical research. METHODS: An anonymous 12-item questionnaire was circulated to patients and doctors at a University Teaching Hospital. Data analysis included descriptive statistics. RESULTS: Five hundred nine participants were included: 261 females (51.3%) and 248 males (48.7%). Three hundred fifty were patients (68.8%) and 159 were doctors (31.2%). Three hundred thirty-four participants were aware of GDPR (65.7%): 116 doctors (73.0%) and 218 patients (62.3%, P = 0.018). 71.1% of doctors were willing to allow their personal data to be processed anonymously as part of a clinical research project compared to 43.4% of patients (P < 0.001). 80.2% of patients believed explicit consent is needed before using personal data in clinical research in comparison to 60.4% of doctors (P < 0.001). Level of education impacted awareness of GDPR (P < 0.001); a higher level of education among patients increased GDPR familiarity (P < 0.001), however failed to impact doctor familiarity (P = 0.117). CONCLUSION: GDPR has introduced complexity to the processing and sharing of personal data among researchers. This study has identified differences in the perception of GDPR and willingness to consent to data being used in clinical research between doctors and patients. Measures to adequately inform prospective research participants on data processing and the evolving landscape of data protection regulation should be prioritised.

Optimal localization strategies for non-palpable breast cancers -A network meta-analysis of randomized controlled trials.

PURPOSE: Mammographic screening programmes have increased detection rates of non-palpable breast cancers. In these cases, wire-guided localization (WGL) is the most common approach used to guide breast conserving surgery (BCS). Several RCTs have compared WGL to a range of novel localization techniques. We aimed to perform a network meta-analysis (NMA) of randomized controlled trials (RCTs) comparing methods of non-palpable breast cancer localization. METHODS: A NMA was performed according to PRISMA-NMA guidelines. Analysis was performed using R packages and Shiny. RESULTS: 24 RCTs assessing 9 tumour localization methods in 4236 breasts were included. Margin positivity and reoperation rates were 16.9% (714/4236) and 14.3% (409/2870) respectively. Cryo-assisted localization had the highest margin positivity (28.2%, 58/206) and reoperation (18.9%, 39/206) rates. Compared to WGL (n = 2045 from 24 RCTs) only ultrasound guided localization (USGL) (n = 316 from 3 RCTs) significantly lowered margin positivity (odds ratio (OR): 0.192, 95% confidence interval (CI): 0.079-0.450) and reoperation rates (OR: 0.182, 95%CI: 0.069-0.434). Anchor-guided localization (n = 52, 1 RCT) significantly lowered margin positivity (OR: 0.229, 95%CI: 0.050-0.938) and magnetic-marker localization improved patient satisfaction (OR: 0.021, 95%CI: 0.001-0.548). There was no difference in operation duration, overall complications, haematoma, seroma, surgical site infection rates, or specimen size/vol/wt between methods. CONCLUSION: USGL and AGL are non-inferior to WGL for the localization of non-palpable breast cancers. The reported data suggests that these techniques confer reduced margin positivity rates and requirement for re-operation. However, caution when interpreting results relating to RCTs with small sample sizes and further validation is required in larger prospective, randomized studies.