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Biomedical subjects

D Stengel

Publications and source records attributed to D Stengel.

At least 19 recordsLinked to original sources
PubMed2006

Biweekly pegylated liposomal doxorubicin in patients with relapsed ovarian cancer: results of a multicenter phase-II trial.

BACKGROUND: The obvious benefit of pegylated liposomal doxorubicin (PLD) for tumour control in recurrent ovarian cancer is frequently offset by severe palmar-plantar erythrodysesthesia (PPE). There is evidence that dose reduction from 50 to 40 mg/m(2) reduces the incidence of PPE without compromising cytotoxic activity. We set out to investigate whether biweekly application further improves the therapeutic index of PLD. PATIENTS AND METHODS: Patients with recurrent ovarian cancer after surgery and adjuvant chemotherapy with platinum and taxane compounds were eligible to participate in this multi-institutional phase II study. PLD was administered at a dose of 20 mg/m(2) every two weeks. Eligible patients had ECOG performance status of < or =2, and sufficient organ function. We employed an optimized two-stage design to test the hypothesis that biweekly application of PLD reduces the frequency of grade III and IV PPE from 25% to 10%. Response and survival were addressed descriptively. RESULTS: Between October 2001 and February 2004, 64 patients with median age of 59 (range 38-81) years were recruited onto this trial. We evaluated 553 (median 7, range 1-25) courses of PLD treatment. Most patients were in their third or fourth line of chemotherapy. PPE was noted in 30 patients (47.6%), but only three participants progressed to grade 3 severity (4.7%, 95% confidence interval 1.0-13.1%). Partial response, stable disease, and tumour progression were observed in 5, 13, and 24 patients, respectively. Median overall and progression-free survival were 18.2 (range, 1.4-34.0) and 4.3 (range 0.5-22.3) months. CONCLUSIONS: Biweekly PLD may reduce the incidence of PPE while retaining efficacy in relapsed ovarian cancer. Our data support the need for a randomized trial to strengthen these assumptions.

Adult↗
PubMed2006

[The clinical use of the ISO-C(3D) imaging system in calcaneus fracture surgery].

We compared in a prospective study including 82 patients treated with ORIF of an intraarticular calcaneus fracture the quality of fluoroscopy, intraoperatively Iso-C(3D) and postoperative CT-scans. Therefore the posterior facet of the calcaneus (PFOC) was divided into three sectors. Joint steps and fracture gaps were detected by two independent investigators and statistically analysed. Another focus was to evaluate if the findings due to intraoperatively Iso-C(3D) assessment performed by the surgeon were correct and subsequently influenced the surgical procedure. There were no statistically differences between the Iso-C(3D)- and CT findings concerning joint steps or fracture gaps in PFOC sectors I-III. With fluoroscopy an assessment of the PFOC sectors I and II was not possible. In six cases (7.3%), intraoperative reduction was redone after performing an Iso-C(3D) scan. In ten cases, 12 malpositioned screws were replaced (12.2%/14.6%). These results suggest that intraoperative 3D Iso-C(3D) imaging provides a high diagnostic reliability. By careful assessment of the images the surgeons receive information which could lead to a change of the operative strategy.

Algorithms↗
PubMed2006

[Surgical management of abdominal injury].

PURPOSE: Accompanying abdominal injuries are frequent in multiply injured patients and are a common cause of death. A search of the literature was performed focusing on key aspects of initial surgical procedures in abdominal injury. METHODS: Literature was searched utilizing PubMed Medline, the Cochrane Central Register of Controlled Clinical Trials, and the German Institute for Medical Documentation and Information (DIMDI) database. The articles were classified according to the level of evidence following the suggestions of the Centre for Evidence Based Medicine. RESULTS: Vertical laparotomy should be favored for the initial surgical therapy of abdominal injury. Especially in instable patients, principles of "damage control surgery" should be applied. In case of hollow organ injury, a primary anastomosis should be made whenever possible. A hand suture is most suitable for this. DISCUSSION: Non-surgical treatment of blunt abdominal injury is gaining in importance. However, if a surgical intervention is recommended, especially in hemodynamic, instable patients, damage control principles should be favored.

Abdominal Injuries↗
PubMed2006

[Do injuries of the upper extremity in geriatric patients end up in helplessness? A prospective study for the outcome of distal radius and proximal humerus fractures in individuals over 65].

In a prospective study 104 patients >or=65 years with distal radius fractures (DRF; n=52) and proximal forearm fractures (PHF; n=52) were followed up for a period of 4 months after injury. As an inception- cohort study, influence on treatment pattern was not part of the examination. A total of 53% of the DRF and 74% of the PHF patients underwent surgery. There were no significant changes in the ability of daily living management (IADL) with either fracture form. Functional outcome was better in PHF than DRF patients. PHF patients showed a high incidence in "fear of falling" throughout the whole study, whereas fear of falling rose significantly in DRF patients. 4% of DRF and 9.6% of PHF patients died during the observation period, while 6% of DRF and even 17% of PHF patients had to give up their own housekeeping. One third of both patient groups did not receive physiotherapy. In only 12% of DRF and 6% of PHF patients was osteoporosis treated. In both groups of patients there was a significant worsening in the ability of walking after injury, leading to two or more new falls in 24% of DRF and 28% of PHF patients.

Accidental Falls↗
PubMed2005

Emergency ultrasound-based algorithms for diagnosing blunt abdominal trauma.

BACKGROUND: Ultrasonography is regarded as the tool of choice for early diagnostic investigations in patients with suspected blunt abdominal trauma. Although its sensitivity is too low for definite exclusion of abdominal organ injury, proponents of ultrasound argue that ultrasound-based clinical pathways enhance the speed of primary trauma assessment, reduce the number of computed tomography scans and cut costs. OBJECTIVES: To assess the efficiency and effectiveness of trauma algorithms that include ultrasound examinations in patients with suspected blunt abdominal trauma. SEARCH STRATEGY: We searched MEDLINE, EMBASE, CENTRAL, CCMED, publishers' databases, controlled trials registers and the Internet. Bibliographies of identified articles and congress abstracts were handsearched. Trials were obtained from the Cochrane Injuries Group's trials register. Authors were contacted for further information and individual patient data. SELECTION CRITERIA PARTICIPANTS: patients with blunt torso, abdominal or multiple trauma undergoing diagnostic investigations for abdominal organ injury. INTERVENTIONS: diagnostic algorithms comprising emergency ultrasonography (US). CONTROLS: diagnostic algorithms without US ultrasound examinations (e.g. primary computed tomography [CT] or diagnostic peritoneal lavage [DPL]). OUTCOME MEASURES: mortality, use of CT and DPL, cost-effectiveness, laparotomy and negative laparotomy rates, delayed diagnoses, and quality of life. STUDIES: randomised controlled trials (RCTs) and quasi-randomised trials (qRCTs). DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion, assessed methodological quality and extracted data. Where possible, data were pooled and relative risks (RRs), risk differences (RDs) and weighted mean differences, each with 95% confidence intervals (CIs), were calculated by fixed- or random-effects modelling, as appropriate. MAIN RESULTS: We identified two RCTs with US in the experimental arm and another with US in the control group. We also considered two qRCTs. Overall, trials were of moderate methodological quality. Few authors responded to our written inquiries seeking to resolve controversial issues and to obtain individual patient data. We were able to pool data from two trials comprising 1037 patients for primary endpoint analysis (i.e. mortality). The relative risk in favour of the no-US arm was 1.4 (95% CI 0.94 to 2.08). Because of a lack of details, the meaning of this observation remains unclear. There was a marginal benefit with US-based pathways in reducing CT scans (random-effects RD -0.46; 95% CI -1.00 to 0.13), offset by trials of higher methodological rigour. No differences were observed in DPL and laparotomy rates. AUTHORS' CONCLUSIONS: There is insufficient evidence from RCTs to justify promotion of ultrasound-based clinical pathways in diagnosing patients with suspected blunt abdominal trauma.

Abdominal Injuries↗
PubMed2005

[Age and survival likelihood of polytrauma patients. "Local tailoring" of the DGU prognosis model].

INTRODUCTION: Age is one of five prognostic parameters identified based on data of the trauma registry of the German Association for Trauma Surgery (DGU). We asked ourselves if the suggested prognostic model provides the same predictive power of data from an independent hospital. Furthermore, we investigated whether age itself or age-associated comorbidity causes an unfavorable prognostic effect. METHODS: The investigation was based on data of 103 multiply injured patients (67 male, 36 female, mean age 35,4+/-SD 19,0 years, ISS 36,8+/-10,9). Data were collected prospectively following the guidelines of the trauma registry of the German Association for Trauma Surgery. Based on documented comorbidities, a risk calculation was performed using the ASA classification. Correlation between age and ASA was analyzed using Spearman's method. The prognostic value of the original model in our patient pool with or without ASA classification, possible interactions, and the discriminatory power of the model were estimated using logistic regression. RESULTS: Attributable mortality was 31,7% (95% CI 22,7-41,7%). Age, ISS, GCS and ASA were included into the final logistic model. Odds ratios of the origin model were reproducible nearly identical in our patinet pool (OR: age 1,048; ISS 1,066; GCS 0,822). In spite of the fact that we have found a strong correlation between age and ASA-Classification (rho=0,60, p<0,0001) there was no prognostic value of comorbidity. CONCLUSION: The suggested prognostic model based on multicenter data evaluation can be applied to a single center with only minimal loss of discriminatory power. In this context, age seems to have a prognostic value independent of comorbidity.

Adult↗
PubMed2005

[Modelling critical information measurement traumatic surgery decisions. "Sequential Information Appraisal Module (SIAM)"].

We studied the quality and quantity of information leading to the emergency physician's decision to intubate severely injured patients on scene. Our aim was to assess intuitive aspects of clinical decision making. The experiment involved three different phases, with a fourth phase examining retest reliability. We used trauma register data from 98 patients. Based on various parameters (physiological data, injury assessment on scene, definite injury pattern), three emergency surgeons were requested to decide on the need for endotracheal intubation.We applied multivariate logistic regression to estimate the likelihood of intubation given certain clinical characteristics or combinations of characteristics. We compared the participants' decisions to those made by "true" emergency physicians on scene. Kappa statistics marked inter-observer agreement beyond chance. The Glasgow Coma Scale (GCS) was the only single predictor of intubation in the ideal test setting (area under the receiver operating characteristics curve [AUC] >98%) as well as on scene (AUC 0.85, 95% confidence interval 0.78-0.92). There was no difference between the discriminatory features of the single item GCS and complex multivariate models that included anatomically defined injury scales (best model in phase 2: AUC 0.96, best model in phase 3: AUC 0.98). Overall inter-observer agreement was substantial in phase 1 (kappa=0.74), fair to moderate in phase 2 (kappa=0.49) and slight to fair in phase 3 (kappa=0.23). Retest reliability ranged from 51% to 91%. Doctors give priority to only a small part of the information available in deciding for or against a particular intervention.

Decision Support Systems, Clinical↗
PubMed2005

Second-line treatment of limb-threatening diabetic foot infections with intravenous fosfomycin.

Diabetic foot infections (DFI) expanding to bones and joints are associated with a poor prognosis of limb salvage. The bactericidal epoxide fosfomycin accumulates in inflamed soft and bone tissue, and may represent a potential treatment option for targeting severe DFI. Fifty-two patients (35 men, 17 women, mean age 62.9 +/- SD 9.2 years) with limb-threatening DFI (that is, Wagner grade 3 and higher) were enrolled in a multi-center compassionate use program of fosfomycin. Twenty-two patients (42.4%) had unsuccessfully been pretreated with other antimicrobials. Besides standard treatment (topical wound care and surgical debridement), eligible subjects received a combination of 8 to 24 g fosfomycin daily, and a conventional antibiotic agent, usually a beta-lactam compound. Treatment duration averaged 14.4 +/- 8.3 days. Limb-sparing surgery was possible in 48 patients (92.3%, 95% confidence interval 81.5-97.9%). Only four participants faced mild drug-related side effects (nausea, rash). Logistic regression analysis showed a trend towards better results with prolonged treatment, whereas a dose increase above 12 g daily did not affect outcomes. In DFI being resistant to conventional antibiotic agents, intravenous fosfomycin offers an effective treatment choice that may increase the likelihood of limb preservation. The present data warrant a larger comparative trial to stabilize effect estimates.

Aged↗
PubMed2004

[A rapid review of the minimum quality problems using total knee arthroplasty as an example. Where do the magical threshold values come from?].

We set out to clarify whether in hospitals with a large volume morbidity and mortality rates after total knee arthroplasty (TKA) can be improved, whether the effects are consistent, and whether minimum recommendable caseloads can be inferred. We conducted a systematic review using MEDLINE, EMBASE, CENTRAL, and CINAHL and performed a hand search without restrictions on language or publication types. We identified 1406 citations, of which 13 studies including 1,110,962 patients met our inclusion criteria. Of these, six studies explored the same administrative data source. Five studies enrolling 448,897 were eligible for quantitative analysis. All studies corresponded to evidence level 2b (prospective or retrospective cohort study with >80% follow-up). We found homogeneous results about hospital mortality. Between 2551 and 821 TKA must be performed by high-volume rather than by low-volume providers to prevent 1 extra death. Absolute event rates are notably small.

Arthroplasty, Replacement, Knee↗
PubMed2004

Dose finding study for combination treatment with topotecan and gemcitabine of patients with recurrent ovarian cancer after failure of first-line chemotherapy with Paclitaxel and platinum.

OBJECTIVES: Topotecan and gemcitabine have shown mono-activity against different solid tumors including recurrent ovarian cancer after failure of platinum- and paclitaxel-containing therapies. Both drugs affect DNA replication, topotecan additionally inhibits the DNA repair process. Efficacy profiles and different mechanisms of action make the combination of both drugs a promising regimen. Therefore the following dose-finding study was conducted to determine the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLT) of this combination. Based on the monotherapy schedules topotecan was given on day 1-5, and gemcitabine on day 1 + 8 every 21 days. PATIENTS AND METHODS: Patients with histologically proven ovarian cancer who relapsed after platinum- and paclitaxel-containing therapy were enrolled. 3 different dose levels were investigated. No individual dose escalation or primary use of cytokines were allowed. RESULTS: 23 patients were enrolled, 50% were pretreated with at least 2 platinum-containing therapies; 80 courses were analyzed for toxicity. Thrombocytopenia and leucopenia were the major DLTs. The MTD for phase II trials is 0.50 mg/m(2) topotecan and 800/600 mg/m(2) gemcitabine. In this dose level only one therapy-related non-hematological adverse event >grade 2 (grade 3 mycotic stomatitis) and one grade 4 thrombocytopenia occurred. Responses were observed in 6 and stable disease in 4 out of 12 evaluable patients. Median survival was 15.3 (95% CI: 13.2-28.6) months. CONCLUSIONS: The results of this phase I study demonstrate the feasibility and tolerability of this new combination in heavily pretreated patients. Based on these results a phase II study was initiated to evaluate the efficacy of this regimen.

Adult↗
PubMed2003

[Clinical trials in orthopedic and trauma surgery: randomized or non-randomized?].

Drawing inferences on a causal relationship between a particular intervention and the observed outcome requires to conduct a clinical experiment which controls for study conditions and systematic errors (bias). This is best to be achieved by randomization in which known and unknown biological risk factors are distributed equally among treatment arms. Trauma and orthopedic surgery,however, occupies an exceptional position in clinical medicine. Random allocation of subjects is often considered difficult because of the tight time frame between patient presentation and the urgent need for surgical treatment, and the dependence of operative results upon technical skills. Evidence of a true treatment effect does not only depend on design issues (i.e., randomized or non-randomized treatment assignment), but on both the prior probability of efficacy and the observed effect size as well. Even though our knowledge of the efficacy of osteosynthesis comparing with, let's say, plaster immobilization or (fictive) placebo therapy is hardly supported by randomized trials, the biologically plausible principle of stable operative fixation of fracture fragments has established itself as the scientific basis to propagate surgical rather than other treatment options. Thus, the efficacy of a medical intervention can be well demonstrated without randomization. Regarding the ultimate goals of stabilization, pain removal, and mobilization,osteosynthesis of a pertrochanteric fracture fits these principles in terms of an all-or-none effect (so called level Ic evidence): without the intervention, effects will not be observed. On the other hand, endpoints such as healing and infection rates or duration of rehabilitation may be severely influenced by confounding factors (e.g., concomitant diseases, age, or gender). Under these circumstances,the goal of quantifying treatment effects of different interventions (i.e., interlocking nails, plates, K-wires) and of discriminating these effects from bias might be solved more reliably by a randomized than by a non-randomized trial.Obviously,the need for randomization relies on the choice of the main endpoint of interest.The postulated overestimation of treatment effects by nonrandomized trials has been proven only for methodologically weak investigations. In contrast, high quality studies led to comparable findings regardless of randomization. In conclusion, there are thinkable alternative designs to randomized trials in trauma surgery, accounting for selected clinical questions and objectives. It must be emphasized that these designs will require a similarly rigorous planning (i.e., study protocols, ethics, sample size considerations) and analysis of the results.

Bias↗
PubMed2003

[Diagnostic efficacy of gadodiamide-enhanced dynamic examination technique in comparison to conventional magnet resonance tomography in exacerbated chronic osteomyelitis].

PURPOSE: To evaluate the diagnostic effectiveness of dynamic gadodiamide-enhanced MRI in discriminating reparative tissue formation from florid inflammation in patients with chronic osteomyelitis. MATERIALS AND METHODS: Subjects with chronic osteomyelitis and clinically suspected exacerbation were consecutively enrolled into a prospective trial. Following conventional contrast-enhanced MRI scanning, a dynamic contrast-enhanced SE sequence was carried out in all patients (acquisition interval 58 s, 11 repetitions with a total acquisition time of 11 minutes). The relative increase of the time-dependent signal intensity was assessed in representative circular regions of interest placed over bone marrow and surrounding soft tissues. As diagnostic reference standard, histologic and intraoperative findings were obtained independently from the result of the index test. The MRI studies were evaluated by two radiologists who were blinded to the findings of the reference test. RESULTS: 30 of 51 patients were subsequently scheduled for surgery (mean age 42.6 +/- 12.7 years, 27 males). 19 cases had a florid granulocytic infection, with 6 cases showing histologic signs of putrid liquefaction. Another 11 patients had chronic-granulating, fibrosing osteomyelitis. The course of the signal-time curves differed significantly between the different pathologic processes (multiple measures ANOVA, p < 0,001) in both bone marrow and soft tissue. The areas under the receiver operating characteristics (ROC) curves of the dynamic sequence as a performance measure to distinguish between acute and chronic infection were 0.73 (95 % confidence interval 0.41 - 1.00) and 0.82 (95 % confidence interval 0.59 - 1.00), respectively. Although no overall difference was found in diagnostic efficacy between conventional and dynamic MRI, the dynamic technique provided important additional information for equivocal conventional results. CONCLUSION: Dynamic contrast-enhanced MRI scanning is a safe and potentially valuable tool to discriminate between florid and chronic inflammation in documented osteomyelitis.

Adult↗
PubMed2003

[Emergency ultrasound for blunt abdominal trauma--meta-analysis update 2003].

Emergency ultrasound has established itself as a key procedure of primary diagnostic work-up for blunt abdominal and multiple trauma. However, in a systematic review published in 2001 ultrasonography turned out to provide an unexpectedly low sensitivity. We conducted an update of this analysis to investigate if test characteristics will be maintained including recent studies. Prospective trials published between January 1957 and January 2003 were identified using the Medline/Oldmedline, Embase and Cochrane Controlled Trials Register databases. The searching strategy comprised a manual search as well as a search along the world-wide web. Qualitative rating was carried out by two investigators using criteria proposed by the Centre for Evidence-Based Medicine, Oxford. We investigated a composite endpoint (i. e., free fluid and/or organ laceration) as well as the single criteria organ injury and free intraabdominal fluid collections. After calculation of two-by-two-tables, Summary Receiver Operating Characteristics (SROC) and Q* values were determined together with their 95% confidence intervals. The Q* value was proposed as the point of intersection where sensitivity equals specificity. In addition, a random effects model was employed to compute common positive and negative likelihood ratios (LR). By assessing the title and/or abstract, 349 of 957 papers contained potentially valid information for the purpose of this review. A total of 67 studies were deemed eligible, nine of which had to be excluded from meta-analysis because of dual publication. This left 58 trials allocating 16,361 subjects for statistical analysis. Despite a trend towards improved study designs observed during the past decade, the included trials were of average methodological quality. Two-thirds of all investigations fulfilled two or less of the six possible quality criteria. The diagnostic reference standard was applied independently in only 40% of all protocols. With regard to the composite endpoint and the sonographic depiction of free fluid, the Q* value was estimated at 0.91, whereas Q* equaled 0.90 for the detection of organ injury. Q* values subsequently decreased with improving study quality and fell clearly below 0.80 in methodologically proper studies. Accounting for a negative LR of 0.23 (composite endpoint) and an assumed prevalence of 35% of intraabdominal injury, a post-test probability of 11% will remain in case of a negative sonogram. In pediatric trauma, ultrasound showed even worse test characteristics (negative LR = 0.43). Thus, in case of a 35% prevalence, the post-test probability has to estimated at 19%. Emergency ultrasound provides high specificity but insufficient sensitivity to reliably rule out intraabdominal injury.

Abdominal Injuries↗