Reproducibility of the CROSS Trial Results in the Multimodal Treatment of Esophageal Cancer in Daily Practice: A Single Center Retrospective Observational Study.

Background: Treatment of nonmetastatic esophageal cancer with curative intention remains a major challenge. Neoadjuvant radiochemotherapy followed by surgery, as described in the CROSS trial in 2012, has been established as a standard of care. With this retrospective observational study, we aimed to analyze the results of the CROSS regimen in daily practice over the last 10 years at the St. Clara Hospital, a Swiss center for esophageal surgery. Methods: To determine the clinical outcome in our daily practice, the medical records of all patients with potentially curable localized esophageal cancer (T1N1 or T2-3N0-1 M0) treated with radiochemotherapy in neoadjuvant intention according to the CROSS regimen were reviewed. The primary endpoint was overall survival. Furthermore, an overall survival analysis of the subgroups of patients who exactly met the inclusion criteria of the CROSS trial with respect to age and weight loss before therapy was performed. The Kaplan-Meier method was used to estimate survival and compared by the log-rank test. Results: From January 2012 to January 2022, 91 patients with T1N1 or T2-3N0-1M0 esophageal cancer underwent neoadjuvant radiochemotherapy according to the CROSS regimen. The median age was 70 years (range 31-86 years), and 26 (29%) patients were over 75 years of age. Weight loss of more than 10% was observed in 23 (25%) patients. 77 (85%) patients underwent esophagectomy, and complete resection (R0) was obtained in 73 (95%) of them. The median overall survival was 41 months, compared to 49.4 months in the CROSS trial. The overall survival rate at 12 months was 85% and at 24 months, it was 68%, very similar to the CROSS trial results. 51% of the patients fully met the inclusion criteria of the CROSS trial with respect to age and pretherapeutic weight loss. Their overall survival rate at 12 months was 94% at St. Clara Hospital versus 82% in the CROSS trial (p=0.04), and at 24 months, 81% versus 67% (p=0.05). Conclusion: Overall, in a center specialized for the multimodal treatment of nonmetastatic esophageal cancer, the results of the CROSS trial seem to be well reproducible in daily practice.

Effect of increased serum 25(OH)D and calcium on structure and function of post-menopausal women: a pilot study.

The purpose was to determine if increasing serum 25(OH)D and calcium in postmenopausal women increased skeletal muscle size, strength, balance, and functional task performance while decreasing muscle fatigue. PCSA of the vastus lateralis increased and ascent of stairs time decreased after 6 months of increased serum 25(OH)D. PURPOSE: The Institute of Medicine recommends ≥ 20 ng/ml of serum 25-hydroxyvitamin D [25(OH)D] for bone and overall health. Serum 25(OH)D levels have been associated with physical performance, postural sway, and falls. The purpose of this study was to determine if increasing postmenopausal women's serum 25(OH)D levels from 20-30 ng/ml to 40-50 ng/ml improved skeletal muscle size, strength, balance, and functional performance while decreasing skeletal muscle fatigue. METHODS: Twenty-six post-menopausal women (60-85 years old) with baseline serum 25(OH)D levels between 20 and 30 ng/ml were recruited. Oral over-the-counter (OTC) vitamin D3 and calcium citrate were prescribed to increase subjects' serum 25(OH)D to levels between 40 and 50 ng/ml, serum calcium levels above 9.2 mg/dl, and PTH levels below 60 pg/ml, which were confirmed at 6 and 12 weeks. Outcome measures assessed at baseline and 6 months included muscle physiological cross-sectional area (PCSA), muscle strength, postural balance, time to perform functional tasks, and muscle fatigue. Repeated measures comparisons between baseline and follow-up were performed. RESULTS: Nineteen subjects completed the study. One individual could not afford the time commitment for the repeated measures. Three individuals did not take their vitamin D as recommended. Two subjects were lost to follow-up (lack of interest), and one did not achieve targeted serum 25(OH)D. Vastus lateralis PCSA increased (p = 0.007) and ascent of stair time decreased (p = 0.042) after 6 months of increasing serum 25(OH)D levels from 20-30 ng/ml to 40-50 ng/ml. Isometric strength was unchanged. Anterior-posterior center of pressure (COP) excursion and COP path length decreased (p < 0.1) albeit non-significantly, suggesting balance may improve from increased serum 25(OH)D and calcium citrate levels. CONCLUSIONS: Several measures of muscle structure and function were sensitive to elevated serum 25(OH)D and calcium levels indicating that further investigation of this phenomenon in post-menopausal women is warranted.

Long-term evaluation of combined prolonged-release oxycodone and naloxone in patients with moderate-to-severe chronic pain: pooled analysis of extension phases of two Phase III trials.

BACKGROUND: While opioids provide effective analgesia, opioid-induced constipation (OIC) can severely impact quality of life and treatment compliance. This pooled analysis evaluated the maintenance of efficacy and safety during long-term treatment with combined oxycodone/naloxone prolonged-release tablets (OXN PR) in adults with moderate-to-severe chronic pain. METHODS: Patients (N = 474) received open-label OXN PR during 52-week extension phases of two studies, having completed 12-week, double-blind, randomized treatment with oxycodone prolonged-release tablets (Oxy PR) or OXN PR. Analgesia and bowel function were assessed at each study visit using 'Average pain over last 24 h scale and Bowel Function Index (BFI), respectively. Treatment Satisfaction Questionnaire for Medication was assessed at study end only. KEY RESULTS: Improvement in bowel function was particularly marked in patients who switched from Oxy PR in the double-blind phase to OXN PR during the extension phase, resulting in a clinically meaningful reduction (≥12 points) in BFI score: at the start of the extension phases, mean (SD) BFI score was 44.3 (28.13), and was 29.8 (26.36) for patients who had received OXN PR in the double-blind phase. One week later, BFI scores were similar for the two groups (26.5 [24.40] and 27.5 [25.60], respectively), as was observed throughout the following months. Fewer than 10% of patients received laxatives regularly. Mean 24-h pain scores were low and stable throughout the extension phases. No unexpected adverse events were observed. CONCLUSIONS & INFERENCES: Pooled data demonstrate OXN PR is an effective long-term therapy for patients with chronic non-cancer pain, and can address symptoms of OIC. No new safety issues were observed which were attributable to the long-term administration of OXN PR.

[Variations of pain in the treatment of one classical acupuncture-point versus one point of Yamamoto's new scalp acupuncture]. / Veränderungen der Schmerzempfindung bei der Akupunktur eines klassischen Akupunkturpunktes versus eines Schädelakupunkturpunktes nach Yamamoto - Eine prospektiv randomisierte, placebo-kontrollierte Einfachblindstudie.

INTRODUCTION: In an experimental design the pain reduction effect of acupuncture is studied and compared to the treatment of a classical acupuncture point and a point of the Yamamoto New Scalp Acupuncture (YNSA). METHODS: Experimental pain stimuli (32 per test person) were set in 42 test persons at the upper calcaneus edge and pain reduction was checked intra-individually by using the following variations of treatment: Acupuncture YNSA basis-point D, Acupuncture at the classical point Xiao Chang Shu = Bl 27, Acupuncture at a placebo point of the head, Acupuncture at a placebo point of the gluteal region. RESULTS: Evaluation of the data as well as a statistical investigation using a bi-factoral variance analysis with repeated measurements of 2 respectively 1 factor yielded following results: There are highly significant differences concerning pain reduction through the stimulation of the YNSA basis-point D and the acupuncture at the classical point Bl 27 (p < 0,0007). There are also highly significant differences concerning the verum and the placebo treatment (p < 0,00006). Further hypothesis of controlling the experimental design were tested. CONCLUSIONS: On the whole, the investigation shows that there is a marked difference between the verum and placebo treatment as well as a difference between the acupuncture of the YNSA basis-point D and the classical acupuncture point Xiao Chang Shu (Bl 27) with regard to pain reduction induced by experimental stimuli at the calcaneus. These differences are significant.

Evaluation of the suitability of a patient data management system for ICUs on a general ward.

The development of the ICUData patient data management system (PDMS) for intensive care units (ICU), by IMESO GmbH, Hüttenberg, Germany, was based on the assumption that processes and therapies at ICU are the most complex with the highest data density compared with those in other wards. Based on experience with the system and on a survey conducted among users at our pain clinic, we evaluated whether the concept of the present software architecture, which sufficiently reproduces processes and data at an ICU, is suitable as a PDMS for general wards. The highly modular and client-centric approach of the PDMS is founded on a message-based communications architecture (HL7). In the beginning of the year 2000, the system was implemented at the pain management clinic (12 beds) of our hospital. To assess its user friendliness, we conducted a survey of medical staff (n=14). From April 1st 2000 to August 31st 2000, all clinical and administrative data of 658 patients at the pain management clinic were recorded with the PDMS. From the start, all users had access to data and information of other connected data management systems of the hospital (e.g. patient administrative data, patient clinical data). Staff members found the system mostly useful, clearly presented, practical, and easy to learn and use. Users were relatively satisfied with stability and performance of the program but mentioned having only limited knowledge of the program's features. The need for external support during a computer crash was rated negatively. Despite the need for further usage training and improved program performance, the software architecture described seems to be a promising starting point for the construction of a PDMS for general wards.

Hemodynamic, cardiac, and electrolyte effects of low-dose aerosolized terbutaline sulfate in asthmatic patients.

STUDY OBJECTIVE: Aerosolized beta2-agonists have been associated with increased morbidity in asthmatics. These drugs cause transient increases in heart rate and decreases in serum potassium levels after these drugs are first utilized. This study is designed to elucidate whether beta-adrenergic tolerance to the hemodynamic, cardiac, and electrolyte effects of inhaled terbutaline occurs during 14 days of maintenance therapy. DESIGN: Eight patients with stable asthma weaned off beta2-agonist therapy were studied in a randomized, double-blinded, placebo-controlled study utilizing aerosolized terbutaline, 400 microg q6h. Hemodynamic measurements and M-mode echocardiography were performed before and 15 and 30 min after the initial dose of terbutaline or placebo and after a dose of aerosolized terbutaline after 14 days of aerosolized terbutaline maintenance therapy. Holter monitors were worn on the first day of placebo or terbutaline therapy and on day 14 of terbutaline therapy. Plasma potassium, bicarbonate, and glucose levels, pH, renin activity, and serum insulin and aldosterone levels were measured before and after 24 and 48 h after terbutaline or placebo therapy and after 14 days of aerosolized terbutaline maintenance therapy. RESULTS: Terbutaline increased cardiac index and decreased systemic vascular resistance greater after 14 days of therapy compared with the first dose (5.2+/-0.5 vs 4.4+/-0.6 L/min/m2; p<0.05; and 760+/-62 vs 1,016+/-118 dyne x s x cm(-5), p<0.01). After 14 days of terbutaline therapy, the mean maximum heart rate and number of episodes of heart rate > 100 beats/min were higher compared with the other study day (p<0.05). Plasma potassium level decreased from 4.29+/-0.09 to 3.65+/-0.16 mmol/L after 24 h of terbutaline and to 3.90+/-0.11 mmol/L after 48 h. Plasma potassium level returned to baseline after 14 d of terbutaline therapy. Plasma glucose and serum insulin levels rose significantly 24 h and 48 h after terbutaline and returned to baseline after 14 d of terbutaline therapy. Serum aldosterone level decreased significantly as serum potassium level decreased in the first 48 h of terbutaline therapy but returned to baseline levels after 14 d of terbutaline. CONCLUSIONS: Cardiovascular beta2-receptors in patients with stable asthma do not develop tolerance to the effects of low-dose aerosolized terbutaline after 14 days of maintenance therapy. In contrast, the homeostatic mechanisms regulating serum potassium develop tolerance to low-dose terbutaline maintenance therapy. Lack of cardiovascular tolerance to maintenance doses of aerosolized beta2-agonists may be important in increased morbidity if excessive amounts of these drugs are administered during asthma exacerbations.

[The effect of needle type and immobilization on postspinal headache]. / Die Bedeutung von Nadeltyp und Immobilisation für den postspinalen Kopfschmerz.

UNLABELLED: Post-dural puncture headache (PDPH) is a significant complication of spinal anaesthesia. Diameter and tip of the needle as well as the patient's age have been proven to be important determinants. The question of whether post-operative recumbency can reduce the risk of PDPH has not been answered uniformly. And besides, some studies referring to this subject reveal methodical failures, for example, as to clear definition and exact documentation of post-operative immobilization. Furthermore, fine-gauge needles (26G or more) have not been investigated yet. The first aim of our study was therefore to examine the role of recumbency in the prevention of PDPH under controlled conditions using thin needles. Secondly, we wanted to confirm the reported prophylactic effect of needles with a modified, atraumatic tip (Whitacre and Atraucan) by comparing them to Quincke needles of identical diameter. Most of the former investigators compared Quincke with atraumatic needles of different size regardless of the known influence of the diameter on PDPH. PATIENTS AND METHODS: In a prospective study we included 481 consecutive patients undergoing a total of 500 orthopaedic operations under spinal anaesthesia. The latter was performed in a standardized manner (patient sitting, midline approach, needle with parallel bevel direction), using four different needles allocated randomly (26-gauge and 27-gauge needles with Quincke tip, 26-gauge Atraucan and 27-gauge Whitacre cannula). Half of the patients were instructed to stay in bed for 24 h (horizontal position without raising head), the others to get up as early as possible. An anaesthesiologist visited the patients on the fourth postoperative day or later and questioned them about headache and duration of recumbency. Additionally, the patients had to fill out a questionnaire 1 week after surgery. Any postural headache was considered as PDPH. RESULTS: The four groups of different needles had homogeneous demographic characteristics (see Table 1). A total of 47 patients (9.4%) developed PDPH. The incidence was highest after puncture with a 26-gauge Quincke cannula (17.6%) with a significant difference compared to the other needles (see Table 2). PDPH incidence correlated well with increasing age and number of dural punctures, but showed no relation to sex, patient's history of headache or experience of the anaesthesiologist. Only about half of the patients (60.5%) followed the instructions regarding mobilization or recumbency. The duration of strict bed rest did not influence the development of PDPH: The overall incidence was 9.4% in the recumbency group and 8.8% in the group of early ambulation. In all, 45 patients suffered from ordinary not posture-related headache. CONCLUSIONS: The significantly higher incidence of PDPH after spinal anaesthesia with 26-gauge Quincke needles compared to the 27-gauge Quincke and the 26-gauge Atraucan group confirmed the importance of both needle diameter and design of its tip. The Atraucan cannula has not been examined in a controlled study (in comparison with Quincke needle of the same diameter) before. In accordance with other investigators we found patient's age and number of puncture attempts as additional predictors of PDPH. Consequent bed rest, however, was not able to reduce its incidence. Our studies reveal the poor compliance of patients with regard to mobilization/immobilization, a problem which possibly has not been considered enough in former studies examining the influence of bed rest on PDPH. Based on the literature and the present findings, we recommend using thin needles with atraumatic tips for spinal anaesthesia if possible. Recumbency presents an avoidable stress for patients as well as medical staff and should no longer be ordered.

Effect of normothermic blood cardioplegia on postoperative conduction abnormalities and supraventricular arrhythmias.

BACKGROUND: Conduction defects and supraventricular tachycardia (SVT) are common after myocardial revascularization using current methods of cold hyperkalemic blood or crystalloid cardioplegia. The current retrospective study was undertaken to assess the influence of normothermic blood cardioplegia on conduction defects and SVT. METHODS AND RESULTS: The initial 92 patients underwent cardiopulmonary bypass (CPB) at 28 degrees C and blood cardioplegia at 6-8 degrees C. The subsequent 120 patients underwent CPB and blood cardioplegia at 37 degrees C. In all patients, cardioplegia was initially given by a combined antegrade/retrograde technique. The incidence of new postoperative conduction disturbances was significantly less in the normothermic group (p < 0.001): 27.5% versus 57.6% immediately after surgery; 9.2% versus 41.3% 1 day after surgery; 4.2% versus 32.6% 2 days after surgery; 1.7% versus 19.6% on hospital discharge; and 1.7% versus 17.4% on late follow-up. The incidence of supraventricular arrhythmias was not statistically different: 40.0% warm versus 42.4% cold. The groups were identical except that mean cross-clamp times were significantly longer (73.8 versus 60.1 minutes), mean number of grafts were significantly higher (3.7 versus 3.4), and mean cardioplegia volume was significantly greater (5,627 versus 3,710 ml) in the warm group (p < 0.05). In addition, the warm group had a higher incidence of prior transmural anterior myocardial infarctions (35% versus 9.8%, p < 0.001) and emergency operation (16.7% versus 6.5%, p < 0.05). Creatine kinase (CK) MB release was significantly less in the warm group immediately after operation (24.9 versus 60.9 units/l) and on POD1 (19.2 versus 46.5 units/l) (p < 0.001). CONCLUSIONS: Normothermic cardioplegia is associated with a marked decrease in new and permanent conduction disturbances and postoperative CK-MB release. This suggests that a significant factor in the pathogenesis of conduction blocks is cold-related injury. Supraventricular arrhythmias were not affected by the type of cardioplegia given.

The high-affinity K+-translocating ATPase complex from Bacillus acidocaldarius consists of three subunits.

Cells of the thermoacidophilic bacterium Bacillus acidocaldarius express a high-affinity K+-uptake system when grown at low external K+. A vanadate-sensitive, K+- and Mg2+-stimulated ATPase was partially purified from membranes of these cells by solubilization with a non-ionic detergent followed by ion-exchange chromatography of the extract. Combinations of non-denaturing and denaturing electrophoretic separation methods revealed that the ATPase complex consisted of three subunits with molecular weights almost identical to those of the KdpA, B and C proteins, which together form the Kdp high-affinity, K+-translocating ATPase complex of Escherichia coli. The affinity of the partially purified ATPase from B. acidocaldarius for its substrates K+ (Km 2-3 microM) and ATP (Km 80 microM), its stimulation by various divalent cations, and its inhibition by vanadate (Ki 1-2 microM), bafilomycin A1 (Ki 20 microM), DCCD (Ki 200 microM) or Ca2+ were also similar to those of the E. coli enzyme, indicating that the two K+-translocating ATPases have almost identical properties.

Developing and operationalizing a product/service classification system for health care providers.

A variety of classification systems have been presented since 1923. They have been directed toward classifying consumer goods, industrial goods, services, and ideas. The author assimilates several systems into a single system and describes two tools for operationalizing it. Examples and figures are presented and discussed.

Comparison of visual estimate with digital caliper measurement of coronary artery stenosis.

We compared visual estimate and digital caliper measurement of coronary stenoses, utilizing both a 50% and 70% diameter reduction as a definition of significance and both experienced angiographers and cardiology fellows as readers. Ten angiograms were interpreted twice, using the different methods, by four readers, two months apart. The angiograms were divided into 12 vessel segments. Stenoses were judged more severe by visual estimate in 11 segments. Seven of twelve segments had significant differences between readers using the visual estimate, but no significant differences were obtained using caliper measurements. Variability was highest for fellows using the visual method. Interobserver agreement was highest using the digital caliper and the 70% criteria. Intraobserver agreement was most dependent on the amount of time taken in film interpretation. The digital caliper appears to be preferable in interpreting angiograms, particularly for cardiology fellows.

Data-base marketing: a tool for health care administration.

This article discusses how a health care institution's records can be used to create a data base that in turn can be used in administrative decision making. Topics such as segmentation, positioning, and tracking by using data-base manipulations and census overlays are discussed.

Nurses as image emissaries: are role conflicts impinging on a potential asset for an internal marketing strategy?

This article addresses role conflict and image problems nurses have with role partners. If these problems were corrected, nurses could be valuable assets in a "team selling" effort to help hospitals build their images. This research integrates sales management concepts and cites literature alluding to sales management research on identical problems.

"Telemarketing" hospital services: benefits, pitfalls and the planning process.

"Telemarketing" is an innovative concept used by many firms to increase the efficiency and effectiveness of product delivery efforts. It can be used by hospitals to benefit both patients and physicians. Further, it can be a tool that, if used properly, can improve the image of the hospital and assist in positioning the organization uniquely among its competitors. This paper discusses the exploratory nature, potential problems, and benefits of telemarketing hospital services and offers pre- and post-implementation considerations. This paper also provides an outline of a sample marketing plan that could serve as an initial model for hospitals that might consider this unique marketing approach.

Psychographic analysis of nursing students: implications for the marketing and development of the nursing profession.

Understanding the nursing student's personality composition is a key to maintaining a high-quality recruiting campaign to replenish and expand the profession. Nursing schools should target their recruiting efforts toward the personality types that would be most successful in the profession.

Reward preferences of nurses: a marketing concept viewpoint.

A survey of 500 nurses in a midwestern urban area was conducted to determine their preferences for intrinsic and extrinsic rewards in their jobs. This study indicates that in light of the expectancy/valence principle of motivation, hospitals and other employers of nursing services that individualize reward offerings should be in a much better position to recruit, and retain, nurses.

Spontaneous cure of infected left atrial myxoma following embolization.

A patient with prolonged duration, bacterial infection, and echocardiographic disappearance of an atrial myxoma following embolization is discussed. Following aortic saddle embolus, all echocardiographic manifestations of the patient's left atrial myxoma disappeared. Previous cases of infected atrial myxomas are reviewed. The necessity of early surgical intervention, despite active infection, is discussed.