A prospective, multi-centre, follow-up clinical study evaluating the safety and effectiveness of a 24mg/ml sodium hyaluronate soft tissue filler.

Highly concentrated hyaluronic acid dermal fillers commonly contain 20 mg/ml sodium hyaluronate. The soft tissue filler SF 24 contains 24 mg/ml sodium hyaluronate. It is a viscoelastic gel, which is moderately cross-linked and specifically designed to correct moderate to deep wrinkles and folds of facial skin.To evaluate the long-term safety and effectiveness of the SF 24 for facial augmentation.The primary endpoints were effectiveness and safety, which were measured by investigators' assessment of wrinkle/ fold/ defect severity and reaction severity, respectively. The Global Esthetic Improvement Scale (GAIS) evaluated secondary endpoints, such as patient and physician satisfaction. Data collection occurred at treatment date (day 0) and at each visit set at an interval of 21 days, 121 days, 213 days, and 395 days. A total of 74 individuals (3 male and 71 female) received treatment with SF 24 across five sites. The baseline value (2. 70) of wrinkle and fold severity was reduced to 1.22 directly after treatment and remained improved even after 273 days at 1.59. The improvements compared to baseline were all significant (p < .001). The injection-related reactions were mainly short-term (1-7 days), mild to moderate in severity, and resolved without intervention. SF 24 is safe and effective for facial volume augmentation. It shows long-lasting (9 months) results in treated patients.

The Use of a Self-Occluding Topical Anasthetic in Daily Practice: A Non-Interventional Study.

INTRODUCTION: A variety of topical anesthetic creams are available to reduce pain associated with dermatological procedures. Pliaglis is a self-occluding eutectic mixture of lidocaine and tetracaine. STUDY OBJECTIVES: To evaluate the post-marketing safety profile of Pliaglis and efficacy in terms of pain reduction, product satisfaction, and daily practice use prior to pre-defined dermatological procedures. METHODS: A prospective, non-interventional study conducted at 44 sites in four European countries; 581 patients were treated prior to dermatological procedures such as pulsed-dye laser therapy, laser-assisted hair removal, non-ablative laser resurfacing, dermal filler injections, and vascular access. Efficacy was assessed by patients and investigators and included pain intensity (visual analogue scale [VAS]), satisfaction, and adequacy of pain relief. Safety was evaluated by adverse event (AE) reporting. RESULTS: In 75% of the performed procedures, patients scored the pain experienced during the procedure as ≤30 mm on the VAS and most were very satisfied or satisfied with the pain reduction. The investigators assessed the product as providing adequate anesthesia in 97% of the performed procedures and were mostly very satisfied or satisfied with the convenience of use (79%) and tolerability (95%). Twenty-four AEs were reported in 18 (3%) patients. DISCUSSION: Most patients experienced mild pain only as evident by the ≤ 30 mm VAS scores. Patients and investigators were aligned with regards to both product satisfaction and their opinion on adequacy of pain reduction. The AE frequency was low compared to previous studies, possibly relating to different ways of collecting AEs. CONCLUSION: Pliaglis was well-tolerated and provided adequate pain reduction prior to dermatological procedures. www.clinicaltrials.gov (NCT01800474).

J Drugs Dermatol. 2018;17(4):413-418.

Partial study data have been presented at the Anti-Aging Medicine European Congress (AMEC), Paris; October, 24-25, 2014, and the European Academy of Dermatology and Venereology (EADV), Istanbul; October 2-6, 2013.

How assessment drives learning in neurosurgical higher training.

UNLABELLED: Certifying the competence of neurosurgeons is a process of critical importance to the people of Australia and New Zealand. This process of certification occurs largely through the summative assessment of trainees involved in higher neurosurgical training. Assessment methods in higher training in neurosurgery vary widely between nations. However, there are no data about the 'utility' (validity, reliability, educational impact) of any national (or bi-national) neurosurgical training system. The utility of this process in Australia and New Zealand is difficult to study directly because of the small number of trainees and examiners involved in the certifying assessments. This study is aimed at providing indirect evidence of utility by studying a greater number of trainees and examiners during a formative assessment conducted at a training seminar in Neurosurgery in April 2005. AIM: To evaluate an essay examination for neurosurgical trainees for its validity, reliability and educational impact. METHODS: A short answer essay examination was undertaken by 59 trainees and corrected by up to nine examiners per part of question. The marking data were analysed. An evaluation questionnaire was answered by 48 trainees. Eight trainees who successfully passed the Fellowship examination who had also taken the short essay examination underwent a semi-structured interview. RESULTS: The essay examination was found to be neither reliable (generalisability coefficient of 0.56 if the essay paper had comprised 6 questions) nor valid. Furthermore, evidence suggests that such an examination may encourage a pursuit of declarative knowledge at the expense of competence in performing neurosurgery. CONCLUSION: This analysis is not directly applicable to the Fellowship examination itself. However, this study does suggest that the effect of assessment instruments upon neurosurgical trainees' learning strategies should be carefully considered.

Microvascular decompression for trigeminal neuralgia: recurrences and complications.

BACKGROUND: The purpose of this study was to review the complications and pain recurrences after microvascular decompression (MVD) for trigeminal neuralgia. METHODS: This is a retrospective review of 156 patients undergoing MVD in the last 25 years at Princess Alexandra Hospital, Brisbane, Australia. Patients were contacted by telephone and a questionnaire was used for the interview. RESULTS: The probability of becoming pain free after MVD in our study was 0.93. There were no deaths and the incidence of serious complication was 2%. Our complication profile is similar to other authors. Pain recurrences occurred in 18% of patients over a 25 year period. This was most likely within two years of surgery and thereafter occurred at a rate of 2-3.5% a year. Seventy-four percent of patients were still pain free at 10 years. In half of the patients the recurrence was not as severe as the initial occurrence of pain. Thirty percent of recurrences occurred on the opposite side. Eighteen percent of patients were not pain free despite any intervention. CONCLUSIONS: Microvascular decompression in experienced hands has an excellent pain outcome in the majority of patients. Major complications are uncommon.

The neurosurgical training curriculum in Australia and New Zealand is changing. Why?

The Neurosurgical Advanced Training curriculum of the Royal Australasian College of Surgeons (RACS) is currently undergoing change. Given the high standard of neurosurgery in Australia and New Zealand, it may be questioned why such change is necessary. However, the curriculum has not kept pace with developments in professional practice, educational practice or educational theory, particularly in the assessment of medical competence and performance. The curriculum must also adapt to the changing training environment, particularly the effects of reduced working hours, reducing caseloads due to shorter inpatient hospital stays and restricted access to public hospital beds and operating theatres, and the effects of sub-specialisation. A formal review of the curriculum is timely.