How to measure success in lower extremity reconstruction, which outcome measurements do we use a systematic review and metanalysis.

Different factors have to be considered and weighted in the treatment algorithm of lower extremity reconstruction. A combination of both clinicians' and patients' perspectives is necessary to provide a conclusive picture. Currently, there aren't any standardized and validated measurement data sets for lower extremity reconstructions. This makes it necessary to identify the relevant domains. We, therefore, performed a systematic review and metanalysis of outcome measurements and evaluated their ability to measure outcomes after lower extremity reconstruction. A systematic review and metanalysis according to the 'Preferred Reporting Items for Systematic Reviews and Meta-Analyses' protocol were performed for studies reporting at least one structured outcome measurement of lower extremity reconstruction. Both Patient (PROMs)- and Clinician reported outcome measurements (CROMs)were analyzed. Of the 2827 identified articles, 102 were included in the final analysis. In total 86 outcome measurements were identified, 34 CROMs, 44 PROMs and 8 (9.3%) outcome measurements that have elements of both. Twenty-four measure functional outcome, 3 pain, 10 sensations and proprioception, 9 quality of life, 8 satisfaction with the result, 5 measure the aesthetic outcome, 6 contours and flap stability and 21 contain multidomain elements. A multitude of different outcome measurements is currently used in lower extremity reconstruction So far, no consensus has been reached on what to measure and how. Validation and standardization of both PROMs and CROMs in plastic surgery is needed to improve the outcome of our patients, better meet their needs and expectations and eventually optimize extremity reconstruction by enabling a direct comparison of studies' results.

Complications of facial cosmetic botulinum toxin A injection: analysis of the UK Medicines & Healthcare Products Regulatory Agency registry and literature review.

BACKGROUND: Botulinum toxin A (BoNT-A) injection is one of the most frequently undertaken procedures in aesthetic medicine. The Medicines & Healthcare products Regulatory Agency (MHRA) is the government body in the United Kingdom (UK) mandated to ensure that the provision and administration of medicines is safe. We analyzed adverse events of facial cosmetic BoNT-A injections reported to the MHRA and assessed whether the incidence of reported adverse events in this government registry is comparable to published retrospective and prospective studies. METHODS: A freedom of information (FOI) request was submitted to the MHRA to obtain recorded complications of BoNT- A. Complications reported to the MHRA between 1991 and 2020 were analyzed. Only cases with BoNT-A where the indication was specified as for facial cosmetics were included in the analysis. Additionally, the literature was reviewed on adverse events of facial cosmetic BoNT- A injections, and a statistical meta-analysis of complication rates was carried out. RESULTS: A total of 188 adverse events of aesthetic BoNT-A injections were reported to the MHRA. The literature search resulted in 30 studies and a total of 17,352 injection sessions, where the complication rate was 16% (95% CI = 8% to 25%). Frequent adverse events included localized skin reactions such as bruising with an incidence of 5% (95% CI = 3% to 7%), headache in 3% (95% CI = from 1% to 5% ), and facial paresis in 2% (95% CI = 1% to 3%) of injection sessions. CONCLUSIONS: This is the first paper to obtain and evaluate data on adverse events of BoNT-A from the MHRA. An estimate of the likely complication rate of aesthetic BoNT-A in the UK, according to the MHRA database, is significantly lower than the rate recorded from our meta-analysis of the international literature. This suggests that the MHRA may be underestimating the adverse events of aesthetic BoNT-A treatment, which would have implications for patient safety and informed consent. Therefore, legislative changes may be required to ensure more robust reporting of aesthetic BoNT-A in the UK.