The PARTNER trial of neoadjuvant olaparib with chemotherapy in triple-negative breast cancer.

PARTNER is a prospective, phase II-III, randomized controlled clinical trial that recruited patients with triple-negative breast cancer1,2, who were germline BRCA1 and BRCA2 wild type3. Here we report the results of the trial. Patients (n = 559) were randomized on a 1:1 basis to receive neoadjuvant carboplatin-paclitaxel with or without 150 mg olaparib twice daily, on days 3 to 14, of each of four cycles (gap schedule olaparib, research arm) followed by three cycles of anthracycline-based chemotherapy before surgery. The primary end point was pathologic complete response (pCR)4, and secondary end points included event-free survival (EFS) and overall survival (OS)5. pCR was achieved in 51% of patients in the research arm and 52% in the control arm (P = 0.753). Estimated EFS at 36 months in the research and control arms was 80% and 79% (log-rank P > 0.9), respectively; OS was 90% and 87.2% (log-rank P = 0.8), respectively. In patients with pCR, estimated EFS at 36 months was 90%, and in those with non-pCR it was 70% (log-rank P < 0.001), and OS was 96% and 83% (log-rank P < 0.001), respectively. Neoadjuvant olaparib did not improve pCR rates, EFS or OS when added to carboplatin-paclitaxel and anthracycline-based chemotherapy in patients with triple-negative breast cancer who were germline BRCA1 and BRCA2 wild type. ClinicalTrials.gov ID: NCT03150576 .

Validation of a cost-effective appendicectomy model for surgical training.

BACKGROUND: Appendicitis is a commonly occurring condition worldwide. The gold standard treatment is appendicectomy. Although training models are commercially available for this procedure, they are often associated with high cost. Here we present a cost-effective model. AIM: To establish construct validity of a cost-effective laparoscopic appendicectomy simulation model. METHODS: Three groups of surgeons were recruited; novices (n = 31), of intermediate expertise (n = 13) and experts (n = 5) and asked to perform a simulated laparoscopic appendicectomy using the new model. Their performance was assessed by a faculty member and compared between the three groups using a validated scoring system (Global Operative Assessment of Laparoscopic Skills [GOALS] score). RESULTS: One-way ANOVA test showed a significant difference in task performance between groups (p < 0.0001). Post-hoc comparisons after the application of Bonferroni correction (statistically significant p value <0.017) demonstrate a significant difference in performance between all groups for all GOALS categories as well as the total score. Effect size calculations showed that experience level had moderate (Eta-squared >0.5 and <0.8) and significant (>0.8) impact on the performance of the simulated procedure. CONCLUSION: The model described in this study is cost-effective, valid and can adequately simulate appendicectomy. The authors recommend inclusion of this model to postgraduate surgical training.

Is patient-specific pre-operative preparation feasible in a clinical environment? A systematic review and meta-analysis.

Technical difficulty of an operation is associated with patient and disease characteristics, indicating the necessity for surgeons to exercise patient-specific preparation. Such methods have been shown to be effective in the simulation suite, however, application in a real clinical environment has been sporadic. This systematic review attempts to answer if patient-specific preparation in challenging surgical procedures is feasible. A systematic review of OvidMedline, Embase and all Evidence Based Medicine review databases, was conducted in search of studies who described surgical rehearsals in all specialties. Following the application of defined inclusion and exclusion criteria relevant data were extracted and summarised. Descriptive synthesis was performed for all included studies and meta-analysis of data was applied when possible. Of fourty-nine studies included, thirty-seven were case-series, ten were non-randomised comparative trials and two randomised controlled trials. Accuracy of applied methods ranged from 66.7 to 100% and a good outcome was seen in 60-100% of operations. Meta-analysis of studies comparing rehearsals to real procedures (same patients) showed that simulated procedures were significantly faster than real ones (SMD = -1.56 [-2.19, -0.93] p < 0.00001) but were similar in other outcomes (fluoroscopy time: SMD = -0.1 [-0.63, 0.42] p = 0.7, fluoroscopy volume: SMD = -0.43[-0.97, 0.11], p = 0.12). Meta-analysis of studies comparing pre-operative rehearsals to standard treatment (two distinct groups of patients), demonstrated that real procedures were performed quicker if pre-operative rehearsal took place (SMD = -0.47 [-0.79, -0.16], P = 0.003) but the immediate clinical outcome was similar for practiced and not practiced operations (SMD =0.03[-0.23, 0.29], p = 0.82). Current evidence suggests that patient-specific pre-operative preparation is feasible and safe and decreases operational time.

Patient-specific mental rehearsal with interactive visual aids: a path worth exploring?

BACKGROUND: Surgeons of today are faced with unprecedented challenges; necessitating a novel approach to pre-operative preparation which takes into account the specific tests each case poses. In this study, we examine patient-specific mental rehearsal for pre-surgical practice and assess whether this method has an additional effect when compared to generic mental rehearsal. METHODS: Sixteen medical students were trained how to perform a simulated laparoscopic cholecystectomy (SLC). After baseline assessments, they were randomised to two equal groups and asked to complete three SLCs involving different anatomical variants. Prior to each procedure, Group A practiced mental rehearsal with the use of a pre-prepared checklist and Group B mental rehearsal with the checklist combined with virtual models matching the anatomical variations of the SLCs. The performance of the two groups was compared using simulator provided metrics and competency assessment tool (CAT) scoring by two blinded assessors. RESULTS: The participants performed equally well when presented with a "straight-forward" anatomy [Group A vs. Group B-time sec: 445.5 vs. 496 p = 0.64-NOM: 437 vs. 413 p = 0.88-PL cm: 1317 vs. 1059 p = 0.32-per: 0.5 vs. 0 p = 0.22-NCB: 0 vs. 0 p = 0.71-DVS: 0 vs. 0 p = 0.2]; however, Group B performed significantly better [Group A vs. B Total CAT score-Short Cystic Duct (SCD): 20.5 vs. 26.31 p = 0.02 η 2 = 0.32-Double cystic Artery (DA): 24.75 vs. 30.5 p = 0.03 η 2 = 0.28] and committed less errors (Damage to Vital Structures-DVS, SCD: 4 vs. 0 p = 0.03 η 2=0.34, DA: 0 vs. 1 p = 0.02 η 2 = 0.22). in the cases with more challenging anatomies. CONCLUSION: These results suggest that patient-specific preparation with the combination of anatomical models and mental rehearsal may increase operative quality of complex procedures.

Adjuvant Endocrine Therapy for Hormone-positive Breast Cancer, Focusing on Ovarian Suppression and Extended Treatment: An Update.

The benefits of five years of adjuvant endocrine therapy for oestrogen receptor (ER)-positive early breast cancer are well established. However, recent evidence suggests that extended endocrine treatment and ovarian suppression in selected groups of patients have significant advantages. In this article, we review the current evidence for adjuvant endocrine therapy in breast cancer with focus on extended adjuvant endocrine therapy and ovarian suppression, and also highlight the advantages and disadvantages of these therapeutic strategies. A literature search was performed through PubMed, Medline, and Cochrane using the following search terms: Endocrine therapy, Tamoxifen, Anastrazole, Ovarian Suppression, Exemestane, Letrozole and STS Inhibitors. All available evidence for adjuvant endocrine therapy was reviewed and summarised to assess the current guidance and the progress of the management of patients with ER-positive breast cancer. Extended endocrine therapy should be tailored according to patient needs dictated by their individual risk factors, molecular type of breast cancer, menopausal status, comorbidities, life style and risk of recurrence. Clinicians ought to discuss with patients the pros and cons of different adjuvant endocrine therapy approaches and highlight the potential side effects and toxicity.

"Take-home" box trainers are an effective alternative to virtual reality simulators.

BACKGROUND: Practice on virtual reality simulators (VRSs) has been shown to improve surgical performance. However, VRSs are expensive and usually housed in surgical skills centers that may be inaccessible at times convenient for surgical trainees to practice. Conversely, box trainers (BT) are inexpensive and can be used anywhere at anytime. This study assesses "take-home" BTs as an alternative to VRS. METHODS: After baseline assessments (two simulated laparoscopic cholecystectomies, one on a VRS and one on a BT), 25 surgical trainees were randomized to two groups. Trainees were asked to practice three basic laparoscopic tasks for 6 wk (BT group using a "take-home" box trainer; VR group using VRS in clinical skills centers). After the practice period, all performed two laparoscopic cholecystectomy, one on a VRS and one on a BT; (i.e., posttraining assessment). VRS provided metrics (total time [TT], number of movements instrument tip path length), and expert video assessment of cholecystectomy in a BT (Global Operative Assessment of Laparoscopic Skills [GOALS] score) were recorded. Performance during pretraining and posttraining assessment was compared. RESULTS: The BT group showed a significant improvement for all VRS metrics (P = 0.008) and the efficiency category of GOALS score (P = 0.03). Only TT improved in the VRS group, and none of the GOALS categories demonstrated a statistically significant improvement after training. Finally, the improvement in VRS metrics in the BT group was significantly greater than in the VR group (TT P = 0.005, number of movements P = 0.042, path length P = 0.031), although there were no differences in the GOALS scores between the groups. CONCLUSIONS: This study suggests that a basic "take-home" BT is a suitable alternative to VRS.

Mental practice with interactive 3D visual aids enhances surgical performance.

BACKGROUND: Evidence suggests that Mental Practice (MP) could be used to finesse surgical skills. However, MP is cognitively demanding and may be dependent on the ability of individuals to produce mental images. In this study, we hypothesised that the provision of interactive 3D visual aids during MP could facilitate surgical skill performance. METHODS: 20 surgical trainees were case-matched to one of three different preparation methods prior to performing a simulated Laparoscopic Cholecystectomy (LC). Two intervention groups underwent a 25-minute MP session; one with interactive 3D visual aids depicting the relevant surgical anatomy (3D-MP group, n = 5) and one without (MP-Only, n = 5). A control group (n = 10) watched a didactic video of a real LC. Scores relating to technical performance and safety were recorded by a surgical simulator. RESULTS: The Control group took longer to complete the procedure relative to the 3D&MP condition (p = .002). The number of movements was also statistically different across groups (p = .001), with the 3D&MP group making fewer movements relative to controls (p = .001). Likewise, the control group moved further in comparison to the 3D&MP condition and the MP-Only condition (p = .004). No reliable differences were observed for safety metrics. CONCLUSION: These data provide evidence for the potential value of MP in improving performance. Furthermore, they suggest that 3D interactive visual aids during MP could potentially enhance performance, beyond the benefits of MP alone. These findings pave the way for future RCTs on surgical preparation and performance.

A Multispecialty Evaluation of Thiel Cadavers for Surgical Training.

BACKGROUND: Changes in UK legislation allow for surgical procedures to be performed on cadavers. The aim of this study was to assess Thiel cadavers as high-fidelity simulators and to examine their suitability for surgical training. METHODS: Surgeons from various specialties were invited to attend a 1 day dissection workshop using Thiel cadavers. The surgeons completed a baseline questionnaire on cadaveric simulation. At the end of the workshop, they completed a similar questionnaire based on their experience with Thiel cadavers. Comparing the answers in the pre- and post-workshop questionnaires assessed whether using Thiel cadavers had changed the surgeons' opinions of cadaveric simulation. RESULTS: According to the 27 participants, simulation is important for surgical training and a full-procedure model is beneficial for all levels of training. Currently, there is dissatisfaction with existing models and a need for high-fidelity alternatives. After the workshop, surgeons concluded that Thiel cadavers are suitable for surgical simulation (p = 0.015). Thiel were found to be realistic (p < 0.001) to have reduced odour (p = 0.002) and be more cost-effective (p = 0.003). Ethical constraints were considered to be small. CONCLUSION: Thiel cadavers are suitable for training in most surgical specialties.

Perceptions About the Present and Future of Surgical Simulation: A National Study of Mixed Qualitative and Quantitative Methodology.

OBJECTIVES: Assess expert opinion on the current and future role of simulation in surgical education. DESIGN: Expert opinion was sought through an externally validated questionnaire that was disseminated electronically. PARTICIPANTS: Heads of Schools of Surgery (HoS) (and deputies) and Training Program Directors (TPD) (and deputies). RESULTS: Simulation was considered a good training tool (HoS: 15/15, TPD: 21/21). The concept that simulation is useful mostly to novices and for basic skills acquisition was rejected (HoS: 15/15, TPDs: 21/21; HoS: 13/15, TPDs: 18/21). Further, simulation is considered suitable for teaching nontechnical skills (HoS: 13/15, TPDs: 20/21) and re-enacting stressful situations (HoS: 14/15, TPDs: 15/21). Most respondents also felt that education centers should be formally accredited (HoS: 12/15, TPDs: 16/21) and that consultant mentors should be appointed by every trust (HoS: 12/15, TPDs: 19/21). In contrast, there were mixed views on its use for trainee assessment (HoS: 6/15, TPDs: 14/21) and whether it should be compulsory (HoS: 8/15, TPDs: 11/21). CONCLUSION: The use of simulation for the acquirement of both technical and nontechnical skills is strongly supported while views on other applications (e.g., assessment) are conflicting. Further, the need for center accreditation and supervised, consultant-led teaching is highlighted.

Effect of Playing Video Games on Laparoscopic Skills Performance: A Systematic Review.

BACKGROUND AND PURPOSE: The advances in both video games and minimally invasive surgery have allowed many to consider the potential positive relationship between the two. This review aims to evaluate outcomes of studies that investigated the correlation between video game skills and performance in laparoscopic surgery. METHODS: A systematic search was conducted on PubMed/Medline and EMBASE databases for the MeSH terms and keywords including "video games and laparoscopy," "computer games and laparoscopy," "Xbox and laparoscopy," "Nintendo Wii and laparoscopy," and "PlayStation and laparoscopy." Cohort, case reports, letters, editorials, bulletins, and reviews were excluded. Studies in English, with task performance as primary outcome, were included. The search period for this review was 1950 to December 2014. RESULTS: There were 57 abstracts identified: 4 of these were found to be duplicates; 32 were found to be nonrelevant to the research question. Overall, 21 full texts were assessed; 15 were excluded according to the Medical Education Research Study Quality Instrument quality assessment criteria. The five studies included in this review were randomized controlled trials. Playing video games was found to reduce error in two studies (P 0.002 and P 0.045). For the same studies, however, several other metrics assessed were not significantly different between the control and intervention group. One study showed a decrease in the time for the group that played video games (P 0.037) for one of two laparoscopic tasks performed. In the same study, however, when the groups were reversed (initial control group became intervention and vice versa), a difference was not demonstrated (P for peg transfer 1 - 0.465, P for cobra robe - 0.185). Finally, two further studies found no statistical difference between the game playing group and the control group's performance. CONCLUSION: There is a very limited amount of evidence to support that the use of video games enhances surgical simulation performance.

Efficacy and Safety of a Biweekly Viscosupplementation Regimen for Knee Osteoarthritis.

Osteoarthritis is the most common form of arthritis in the Western world, causing disabling symptoms in 10% of people older than 55 years. Hyaluronic acid injections can reduce osteoarthritic pain but require three to five doses administered weekly. This preliminary study aims to assess the efficacy of a more flexible viscosupplementation regimen. Patients were given three sodium hyaluronate isotonic solution injections (Ostenil; TRB Chemedica SA, Vouvry, Switzerland), biweekly. They were then asked to record their pain before and after administration of the injections, on a visual analog score. A total of 91 knees were injected. Analysis of the data showed that the viscosupplementation injections significantly reduced the baseline pain within the first 24 to 48 hours post first injection (before injection, 68.8mm; 2 days postinjection, 48.9 mm; p < 0.001); these effects were maintained up to 6 months. No adverse effects were reported. The proposed regimen appears safe and efficient in reducing osteoarthritic pain of the knee joint. A randomized controlled study is needed to confirm these results.