Cost-effectiveness analysis of the Geriatric Fracture Center (GFC) concept: a prospective multicentre cohort study.

INTRODUCTION: Geriatric Fracture Centers (GFCs) are dedicated treatment units where care is tailored towards elderly patients who have suffered fragility fractures. The primary objective of this economic analysis was to determine the cost-utility of GFCs compared with usual care centres. METHODS: The primary analysis was a cost-utility analysis that measured the cost per incremental quality-adjusted life-year gained from treatment of hip fracture in GFCs compared with treatment in usual care centres from the societal perspective over a 1-year time horizon. The secondary analysis was a cost-utility analysis from a societal perspective over a lifetime time horizon. We evaluated these outcomes using a cost-utility analysis using data from a large multicentre prospective cohort study comparing GFCs versus usual care centres that took place in Austria, Spain, the USA, the Netherlands, Thailand and Singapore. RESULTS: GFCs may be cost-effective in the long term, while providing a more comprehensive care plan. Patients in usual care centre group were slightly older and had fewer comorbidities. For the 1-year analysis, the costs per patient were slightly lower in the GFC group (-$646.42), while the quality-adjusted life-years were higher in the usual care centre group (+0.034). The incremental cost-effectiveness ratio was $18 863.34 (US$/quality-adjusted life-year). The lifetime horizon analysis found that the costs per patient were lower in the GFC group (-$7210.35), while the quality-adjusted life-years were higher in the usual care centre group (+0.02). The incremental cost-effectiveness ratio was $320 678.77 (US$/quality-adjusted life-year). CONCLUSIONS: This analysis found that GFCs were associated with lower costs compared with usual care centres. The cost-savings were greater when the lifetime time horizon was considered. This comprehensive cost-effectiveness analysis, using data from an international prospective cohort study, found that GFC may be cost-effective in the long term, while providing a more comprehensive care plan. A greater number of major adverse events were reported at GFC, nevertheless a lower mortality rate associated with these adverse events at GFC. Due to the minor utility benefits, which may be a result of greater adverse event detection within the GFC group and much greater costs of usual care centres, the GFC may be cost-effective due to the large cost-savings it demonstrated over the lifetime time horizon, while potentially identifying and treating adverse events more effectively. These findings suggest that the GFC may be a cost-effective option over the lifetime of a geriatric patient with hip fracture, although future research is needed to further validate these findings. LEVEL OF EVIDENCE: Economic, level 2. TRIAL REGISTRATION NUMBER: NCT02297581.

Needle arthroscopy of the elbow through an anterior transbrachial portal.

Background: Current innovation in needle arthroscopy is improving the safety of anterior portals around the elbow. This study evaluated the proximity to the radial nerve, median nerve, and brachial artery on cadaveric specimens of an anterior portal used for elbow arthroscopy. Methods: Ten fresh-frozen adult cadaveric extremities were used. After marking the cutaneous references, the NanoScope cannula was introduced just lateral to the biceps tendon, through the brachialis muscle and the anterior capsule. Elbow arthroscopy was performed. Dissection was then carefully performed on all specimens with the NanoScope cannula in place. The shortest distance from the cannula to the median nerve, radial nerve, and brachial artery was measured with a handheld sliding digital caliper. Results: The cannula was an average of 12.92 mm away from the radial nerve, 22.27 mm from the median nerve, and 16.8 mm from the brachial artery. Needle arthroscopy performed through this portal allows complete visualization of the anterior compartment of the elbow, as well as direct visualization of the posterolateral compartment. Conclusion: Needle arthroscopy of the elbow through an anterior transbrachialis portal is safe for the main neurovascular structures. In addition, this technique allows complete visualization of the anterior and posterolateral compartments of the elbow through the humerus-radius-ulna space.

Geriatric fracture centre vs usual care after proximal femur fracture in older patients: what are the benefits? Results of a large international prospective multicentre study.

OBJECTIVE: The aim of this study was to determine the effect of treatment in geriatric fracture centres (GFC) on the incidence of major adverse events (MAEs) in patients with hip fractures compared with usual care centres (UCC). Secondary objectives included hospital-workflow and mobility-related outcomes. DESIGN: Cohort study recruiting patients between June 2015 and January 2017. Follow-up was 1 year. SETTING: International (six countries, three continents) multicentre study. PARTICIPANTS: 281 patients aged ≥70 with operatively treated proximal femur fractures. INTERVENTIONS: Treatment in UCCs (n=139) or GFCs (n=142), that is, interdisciplinary treatment including regular geriatric consultation and daily physiotherapy. OUTCOME MEASURES: Primary outcome was occurrence of prespecified MAEs, including delirium. Secondary outcomes included any other adverse events, time to surgery, time in acute ward, 1-year mortality, mobility, and quality of life. RESULTS: Patients treated in GFCs (n=142) had a mean age of 81.9 (SD, 6.6) years versus 83.9 (SD 6.9) years in patients (n=139) treated in UCCs (p=0.013) and a higher mean Charlson Comorbidity Index of 2.0 (SD, 2.1) versus 1.2 (SD, 1.5) in UCCs (p=0.001). More patients in GFCs (28.2%) experienced an MAE during the first year after surgery compared with UCCs (7.9%) with an OR of 4.56 (95% CI 2.23 to 9.34, p<0.001). Analysing individual MAEs, this was significant for pneumonia (GFC: 9.2%; UCC: 2.9%; OR, 3.40 (95% CI 1.08 to 10.70), p=0.027) and delirium (GFC: 11.3%; UCC: 2.2%, OR, 5.76 (95% CI 1.64 to 20.23), p=0.002). CONCLUSIONS: Contrary to our study hypothesis, the rate of MAEs was higher in GFCs than in UCCs. Delirium was revealed as a main contributor. Most likely, this was based on improved detection rather than a truly elevated incidence, which we interpret as positive effect of geriatric comanagement. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02297581.

Recirculant hyperthermic IntraVEsical chemotherapy (HIVEC) in intermediate-high-risk non-muscle-invasive bladder cancer.

Purpose To examine the effectiveness of hyperthermic intravesical chemotherapy (HIVEC™) with mitomycin-C (MMC) for patients with intermediate-high-risk non-muscle invasive bladder cancer (NMIBC). Materials and methods From November 2010 to April 2015, 40 patients with intermediate-high-risk NMIBC received HIVEC™ treatment with a Combat BRS system. Of these patients, 24 received neoadjuvant HIVEC™ treatment (eight weekly instillations) before a transurethral resection of the bladder (TURBT) and 16 received adjuvant HIVEC™ treatment post-TURBT (four instillations weekly + six monthly). The pathological response of each tumour was evaluated after the neoadjuvant treatment. Recurrence rates and adverse effects were evaluated in both groups. Results A total of 40 patients completed the induction therapy: 24 patients received the Neoadjuvant HIVEC™ treatment. Of these patients, 15 (62.5%) showed a complete response. Eight patients (33.3%) showed a partial response, and one patient (4.1%) showed no response at all. The 4-year cumulative incidence of recurrence was 20.8%. The adjuvant HIVEC™ treatment was given to 16 patients. The 2-year cumulative incidence of recurrence was 12.5% for this group. The incidence and severity of side effects were slightly lower in the adjuvant group than in the neoadjuvant group. However, the difference was not statistically significant (p < 0.3). Most of the side effects were low grade and had virtually no effect on the treatment plan, and 97% of patients completed all of the HIVEC™ instillations scheduled. Conclusions The recirculation of hyperthermic MMC using Combat's HIVEC™ treatment is safe and effective and is capable of achieving good success rates in both neoadjuvant and adjuvant settings. This treatment seems to be appropriate for NMIBC intermediate-high-risk patients who cannot tolerate or have contraindications for standard BCG therapy or in cases in which there are supply issues or shortages of BCG.

[Analysis of budgetary impact of moderate and high risk non muscle-invasive bladder cancer by means of neoadjuvant hyperthermia chemotherapy compared to the standard adjuvant treatment with BCG]. / Análisis del impacto presupuedtario del tratamiento mediante quimiohipertermia neoadyuvante en el cáncer vesical no muúculo invasive.

OBJECTIVES: To study the relationship between cost-effectiveness and budgetary impact the application of a neoadjuvant chemo-hyperthermia treatment on 15 patients with NMI multi-recurrent bladder cancer and/or whose risk of recurrence and progression is medium-high, compared with the standard neoadjuvant BCG treatment, has had on the Hospital Comarcal de Monforte de Lemos (Lugo). METHODS: A model was designed from an SNS perspective with a temporary horizon of three years to compare the costs of applying neoadjuvant chemo-hyperthermia on the patients of the clinical test (8 instillations weekly of 80 mg Mitomycin C recirculating at 43 C for an hour prior to carrying out a transurethral resection of the bladder tumor) with the costs of treating 15 patients with the same risk profile with the standard adjuvant treatment of BCG (control group). The effective available costs corresponding to drugs, disposables and those relative to TURBT, cold biopsy and tumor relapse were included. The costs of diagnostic tests and follow-up were discarded from the model because they did not vary between groups. RESULTS: The model built with effective and published cost data establishes a favourable difference in favour of the neoadjuvant treatment with chemo hyperthermia in terms of 3 year costs with a minimum global savings of 10,300€ and 687€ per patient, together with an improvement in the effectiveness of the treatment. These values could reach a minimum savings of 25,960€ and 1,731€ per patient, if a change in protocol is made after the neoadjuvant treatment, which uses the cold biopsy to check the results. Of the 15 patients pre-treated with chemo-hyperthermia, 11 high-risk and 4 medium-risk, 9 have responded completely (absence of residual tumor) and 6 partially (shrinking of the tumor). The number of expected relapses has been reduced from 8 to 2 and progression from 3 to 0. CONCLUSIONS: The neoadjuvant treatment with chemo hyperthermia constitutes a cost-effective therapeutic strategy.

A clinical trial of neoadjuvant hyperthermic intravesical chemotherapy (HIVEC) for treating intermediate and high-risk non-muscle invasive bladder cancer.

PURPOSE: Ths paper reports a pilot/feasibility trial of neoadjuvant hyperthermic intravesical chemotherapy (HIVEC) prior to transurethral resection of bladder tumour (TURBT) for non-muscle invasive bladder cancer (NMIBC). MATERIALS AND METHODS: A pilot/feasibility clinical trial was performed and 15 patients with intermediate to high-risk NMIBC received HIVEC prior to TURBT. HIVEC consisting of eight weekly instillations of intravesical MMC (80 mg in 50 mL) delivered with the novel Combat BRS® system at a temperature of 43 °C for 60 min. Treatment-related adverse effects were measured and patients were followed for 2 years for disease recurrence. RESULTS: A total of 119 HIVEC treatments occurred. Grade 1 adverse events consisted of irritative bladder symptoms (33%), bladder spasms (27%), pain (27%), haematuria (20%) and urinary tract infection (UTI; 14%). Grade 2 adverse events were bladder calcification (7%) and reduced bladder capacity (7%). No grade 3 or higher toxicity was observed. At TURBT, eight patients (53%) were complete responders (pT0) while seven (47%) were partial responders. With a median follow-up of 29 months, the 3-year cumulative incidence of recurrence was 15%. CONCLUSIONS: The Combat BRS® system achieved target bladder temperatures and delivered HIVEC with a favourable side-effect profile. Our pilot trial also provides preliminary evidence of treatment efficacy.