An analysis of the influence of framework aspects on the study design of health economic modeling evaluations

Research and practical guidelines have many implications for how to structure a health economic study. A major focus in recent decades has been the quality of health economic research. In practice, the factors influencing a study design are not limited to the quest for quality. Moreover, the framework of the study is important. This research addresses three major questions related to these framework aspects. First, we want to know whether the design of health economic studies has changed over time. Second, we want to know how the subject of a study, whether it is a process or product innovation, influences the parameters of the study design. Third, one of the most important questions we will answer is whether and how the study’s source of funding has an impact on the design of the research. To answer these questions, a total of 234 health economic studies were analyzed using a correspondence analysis and a logistic regression analysis. All three categories of framework factors have an influence on the aspects of the study design. Health economic studies have evolved over time, leading to the use of more advanced methods like complex sensitivity analyses. Additionally, the patient’s point of view has increased in importance. The evaluation of product innovations has focused more on utility concepts. On the other hand, the source of funding may influence only a few aspects of the study design, such as the use of evaluation methods, the source of data, and the use of certain utility measures. The most important trends in health care, such as the emphasis on the patients’ point of view, become increasingly established in health economic evaluations with the passage of time. Although methodological challenges remain, modern information and communication technologies provide a basis for increasing the complexity and quality of health economic studies if used frequently.     

Elastic stabilisation of proximal humeral fractures with a new percutaneous angular stable fixation device (ButtonFix®): a preliminary report

Introduction

The ButtonFix^® system represents a new angular stable percutaneous fixation device for stabilisation of fractures of the proximal humerus. The purpose of this study was to present a preliminary report of the radiological and clinical outcome after minimally invasive stabilisation of selected proximal humerus fractures with the ButtonFix^®.

Patients and methods

Seventeen patients with fractures of the proximal humerus were treated in our department with the ButtonFix^® system. The mean final follow-up was performed 19 months postoperatively. Follow-up included assessment of postoperative reposition, range of motion, the DASH score, the Constant–Murley score, and the Short Form 36 (SF36).

Results

Twelve patients showed anatomical head-to-shaft angles, four revealed minor valgus replacement, and one minor varus replacement. In one patient unplanned revision surgery was necessary due to early secondary fracture dislocation requiring ORIF with an angular stable form plate. Implant removal was performed after 6 weeks in all patients. At the final follow-up, mean range of motion was: flexion 135°, extension 45°, abduction 142°, internal rotation 51°, and external rotation 62°. The mean Constant–Murley score was 70. The mean DASH score was 26 points and the average SF36 score was 76 points. One patient showed radiological signs of avascular necrosis.

Conclusion

The ButtonFix^® system represents a valuable tool in the treatment of proximal humeral fractures with results indicating fewer complications compared to prior percutaneous fixation devices. Moreover, the ButtonFix^® seems to be able to maintain reduction even in elderly patients with potentially reduced bone mass.     

Finite Volume Evolution Galerkin Methods for the Shallow Water Equations with Dry Beds

We present a new Finite Volume Evolution Galerkin (FVEG) scheme for the solution of the shallow water equations (SWE) with the bottom topography as a source term. Our new scheme will be based on the FVEG methods presented in (Noelle and Kraft, J. Comp. Phys., 221 (2007)), but adds the possibility to handle dry boundaries. The most important aspect is to preserve the positivity of the water height. We present a general approach to ensure this for arbitrary finite volume schemes. The main idea is to limit the outgoing fluxes of a cell whenever they would create negative water height. Physically, this corresponds to the absence of fluxes in the presence of vacuum. Well-balancing is then re-established by splitting gravitational and gravity driven parts of the flux. Moreover, a new entropy fix is introduced that improves the reproduction of sonic rarefaction waves.     

Survival and prognostic factors in chondrosarcoma: results in 115 patients with long-term follow-up

Background and purpose

There have been few long-term studies on the outcome of chondrosarcoma and the findings regarding prognostic factors are controversial. We examined a homogeneous group of patients with primary central chondrosarcoma of bone who were treated according to a uniform surgical protocol at our institution, in order to determine the factors that influence survival and identify potential improvements to our therapeutic algorithm.

Patients and methods

We performed a retrospective analysis of 115 patients with primary central chondrosarcoma of bone who presented with localized disease and who had a minimum follow-up of 5 years after diagnosis. 68 tumors were localized in the extremities and 47 in the axial skeleton or pelvis. 59 patients had a high-grade (II and III) and 56 a low-grade (I) tumor. 94 patients underwent surgical resection with adequate (wide or radical) margins, while 21 patients had inadequate (marginal or intralesional) margins.

Results

Tumor grade and localization were found to be statistically significant independent predictors of disease-related deaths in multivariate analysis. The quality of surgical margins did not influence survival. The AJCC staging system was able to predict prognosis in patients with chondrosarcoma of the extremities, but not in those with tumors of the axial skeleton and pelvis. Long-term survival after secondary metastatic disease was only observed when metastases were resected with wide margins. Patients with metastases who received further treatment with conventional chemotherapy, radiotherapy, and/or further surgery had significantly better survival compared to those who received best supportive care.

Interpretation

The outcome in patients with primary central chondrosarcoma of bone who present with localized disease is mostly affected by tumor-related parameters.Chondrosarcoma is the second most common primary malignant solid tumor of bone, and accounts for approximately 25% of all bone sarcomas (Bertoni et al. 2002). It is largely considered to be resistant to conventional chemotherapy and radiotherapy (Healey and Lane 1986, Campanacci 1999, Gelderbloom et al. 2008). As such, surgical resection has been the cornerstone of treatment for over 50 years (Dahlin and Henderson 1956, Healey and Lane 1986, Gelderbloom et al. 2008). However, in recent years several novel therapeutic approaches have been evaluated in experimental studies (Morioka et al. 2003, Gouin et al. 2006, Klenke et al. 2007, Delaney et al. 2009, Schrage et al. 2009, 2010).There is no consensus on prognostic factors to determine which patients have a higher risk of treatment failure and disease-related deaths, although several papers have addressed this issue (Evans et al. 1977, Pritchard et al. 1980, Gitelis et al. 1981, Björnsson et al. 1998, Lee et al. 1999, Rizzo et al. 2001, Fiorenza et al. 2002). One reason may be that most studies have included patients treated over several decades, with no account for the different surgical criteria, indications, and methods applied over the years. Furthermore, most studies have included patients with short follow-up, despite the fact that a high rate of late recurrence and metastasis has been reported for chondrosarcoma patients compared to those with other primary bone sarcomas (Evans et al. 1977, Pritchard et al. 1980), as well as patients with rare histopathological subtypes that have a distinct biologic behavior (Lee et al. 1999, Bertoni et al. 2002, Gelderbloom et al. 2008) such as dedifferentiated chondrosarcoma, mesenchymal chondrosarcoma, and clear cell chondrosarcoma, thus reducing the validity of the results.The purpose of this long-term retrospective study was to examine a group of patients with primary central chondrosarcoma of bone who presented with localized disease and were treated with a uniform surgical protocol at our institution, in order to determine the factors that influence overall and event-free survival. We further aimed at identifying potential improvements to our therapeutic algorithm.     

Dual-energy computed tomography for the differentiation of uric acid stones: ex vivo performance evaluation

We assessed the potential of dual-energy computed tomography (CT) for the differentiation between uric acid (UA)-containing and non-UA-containing urinary stones. Forty urinary stones of 16 different compositions in two sizes (< and >/= 5 mm) were examined in an ex vivo model. Thirty stones consisted of pure calcium oxalate (whewellite or wheddellite), calcium phosphate (apatite, brushite, or vaterite), ammonium magnesium phosphate (struvite), UA, ammonium acid urate, ammonium phosphate, sodium hydrogen urate, or cystine, and ten stones were of mixed composition (UA-sodium hydrogen urate, whewellite-urate, wheddellite-urate, whewellite-brushite, or whewellite-brushite-struvite). Scans were performed using dual-source CT in a dual-energy mode with the tubes simultaneously operating at 80 and 140 kV. Two readers analysed the data with respect to stone attenuation at each energy level. The stones were classified as UA- or non-UA-containing using manual attenuation measurements and software analysis results. Sensitivity, specificity, PPV, and NPV were calculated using crystallographic stone analysis as the gold standard. Twenty-six out of 40 stones (65%) contained no UA; 14 stones (35%) contained UA. When compared with UA-containing stones, the differences in attenuation values at 80 and 140 kV were significantly (P < 0.001) higher in stones containing no UA. The software automatically mapped 39/40 stones (98%). Only one (2%) 2 mm UA-stone was missed. The software correctly classified all detected stones as UA- or non-UA-containing. The attenuation values of the missed stone were manually plotted into the analysis sheet which allowed for the correct classification of the stone (containing UA). Therefore, the sensitivity, specificity, PPV, and NPV for the detection of UA-containing stones was 100%. Ex vivo experience indicates that differentiation between UA- and non-UA-containing stones can be accurately performed using dual-source dual-energy CT.     

Repair of nerve defects with autotransplants]

Over 15 years (1985-1999) 60 plastic reconstructions of nerve defects with autograft were performed after peripheral nerves injuries of the upper limbs (42 patients), lower limbs (14) and face (4). It is demonstrated that efficacy of surgery depends on period from injury to surgery, age of patient, length of autograft, nature and location of injury, kind of injured nerve. Better results were achieved after operations on peripheral nerves of the upper limbs. After operations on lower limbs more favorable results were achieved in repair of tibial nerve defects. Plastic surgery of facial nerve defects gave satisfactory results. Time from injury to surgery is the main factor essential for surgery result.     

Feasibility of navigated resection of liver tumors using multiplanar visualization of intraoperative 3-dimensional ultrasound data

BACKGROUND: Intraoperative ultrasound is widely used in liver surgery, but primarily for diagnostic purposes. We have developed and evaluated a system for navigated liver resections using on intraoperatively acquired 3-dimensional (3D) ultrasound data. METHODS: Navigation technique based on 3D ultrasound and an optical tracking system. Accuracy of the system was validated experimentally in a tumor model. Subsequently, clinical application was evaluated in 54 patients for resection of central liver tumors. Clinical feasibility and accuracy of the navigation technique were assessed with respect to practicability, adequacy of visualization, and precision of navigated resection (free margin). RESULTS: Evaluation of the system in the tumor model showed a significant increase of the accuracy of navigated resections compared with conventional resection (P < 0.05). Clinical application of 3D ultrasound-based navigation was feasible in 52 of 54 patients. Sufficient visualization was obtained with 2 orthogonal section planes. This navigation strategy provided complete anatomic orientation and accurate position control of surgical instruments. Mean histologic resection margin was 9 mm with a maximum deviation of 8 mm from the planned virtual resection margins. CONCLUSIONS: Optoelectronic navigation with section mode visualization in 2 orthogonal planes does sufficiently display intraoperative 3D data and enables accurate ultrasound-based navigation of liver resections.