Ewing's tumors with primary lung metastases: survival analysis of 114 (European Intergroup) Cooperative Ewing's Sarcoma Studies patients.

PURPOSE: To analyze event-free survival (EFS) and prognostic factors in patients who present with Ewing's tumors (ET) of bone and synchronous pulmonary and/or pleural metastases (ppm). PATIENTS AND METHODS: Of 1,270 patients (pts) registered at the continental office of the German/European Intergroup Cooperative Ewing's Sarcoma Studies (CESS81, CESS86, EICESS92), 114 were diagnosed ET with ppm. Patients underwent neoadjuvant therapy and local treatment of the primary tumor. Whole-lung irradiation 15 to 18 Gy was applied to 75 ppm-pts. EFS and 95% confidence intervals (CIs) were estimated according to the Kaplan-Meier method, and prognostic factors were analyzed by log-rank tests and Cox and logistic regression procedures. RESULTS: On November 1, 1997, at a median time under study of 5.9 years, the 5-year EFS was 0.36 (95% CI, 0.26 to 0.46) and the 10-year EFS was 0.30 (95% CI, 0.19 to 0.41). Thirty-seven of 59 (63%) first relapses involved lung and/or pleura, and the lungs were the only site of relapse in 26 of 59 (44%) ppm-pts. Risk factors identified in univariate and multivariate tests were poor response of the primary tumor toward chemotherapy, metastatic lesions in both lungs, and treatment without additional lung irradiation. CONCLUSION: Chemotherapy response of the primary tumor is a prognostic factor in patients with ET with ppm. Strategies of treatment intensification warrant further evaluation.

Prognostic factors in Ewing's tumor of bone: analysis of 975 patients from the European Intergroup Cooperative Ewing's Sarcoma Study Group.

PURPOSE: To further elaborate on prognostic factors for Ewing's sarcoma of bone and to document improvements in relapse-free survival (RFS) and trends in local therapy over the study period (1977 to 1993). PATIENTS AND METHODS: A retrospective analysis was performed on a combined Gesellschaft Für Pädiatrische Onkologie und Hämatologie/Cooperative Ewing Sarcoma Study and United Kingdom Children's Cancer Study Group/Medical Research Council data set of 975 patients registered with the respective trial offices before the current collaborative European Intergroup Cooperative Ewing's Sarcoma Study trial. Both groups independently undertook studies with similar chemotherapy during the period. RESULTS: The key adverse prognostic factor is metastases at diagnosis (5-year RFS, 22% of patients with metastases at diagnosis v 55% of patients without metastases at diagnosis; P: <.0001). For the group with metastases, there was a trend for better survival for those with lung involvement compared with those with bone metastases or a combination of lung and bone metastases (P: <.0001). In the group of patients with no metastases at diagnosis, multivariate analysis demonstrated that site (axial v other), age-group (< 15 v > or = 15 years), and period of diagnosis had significant influence on RFS (all P: <.005). RFS was superior in the period after 1985 compared with the period before 1985 for nonmetastatic patients (45% v 60%, respectively; P: <.0001) and for metastatic patients (16% v 30%, respectively; P: =.016). Patients who relapsed within 2 years of diagnosis had a less favorable prognosis than patients who relapsed later (5-year survival after relapse, 4% v 23%, respectively; P: <. 0001). There were other changes over the period; in particular, radiotherapy or amputation were more common in the period before 1986, whereas endoprosthetic surgery was widely used in the later period. CONCLUSION: Survival and RFS improved over the period. Prognostic factors are metastases at diagnosis, primary site, and age.

Localized Ewing tumor of bone: final results of the cooperative Ewing's Sarcoma Study CESS 86.

PURPOSE: Cooperative Ewing's Sarcoma Study (CESS) 86 aimed at improving event-free survival (EFS) in patients with high-risk localized Ewing tumor of bone. PATIENTS AND METHODS: We analyzed 301 patients recruited from January 1986 to July 1991 (60% male; median age 15 years). Tumors of volume >100 mL and/or at central-axis sites qualified patients for "high risk" (HR, n = 241), and small extremity lesions for "standard risk" (SR, n = 52). Standard-risk patients received 12 courses of vincristine, cyclophosphamide, and doxorubicin alternating with actinomycin D (VACA); HR patients received ifosfamide instead of cyclophosphamide (VAIA). Tumor sites were pelvis (27%), other central axis (28%), femur (19%), or other extremity (26%). The initial tumor volume was <100 mL in 33% of cases and > or =100 mL in 67%. Local therapy was surgery (23%), surgery plus radiotherapy (49%), or radiotherapy alone (28%). Event-free survival rates were estimated by Kaplan-Meier analyses, comparisons were done by log-rank test, and risk factors were analyzed by Cox models. RESULTS: On May 1, 1999 (median time under study, 133 months), the 10-year EFS was 0.52. Event-free survival did not differ between SR-VACA (0.52) and HR-VAIA (0.51, P =.92). Tumor volume of >200 mL (EFS, 0.36 v 0.63 for smaller tumors; P =.0001) and poor histologic response (EFS, 0.38 v 0.64 for good responders; P =.0007) had negative impacts on EFS. In multivariate analyses, small tumor volumes of <200 mL, good histologic response, and VAIA chemotherapy augured for fair outcome. Six of 301 patients (2%) died under treatment, and four patients (1.3%) developed second malignancies. CONCLUSION: Fifty-two percent of CESS 86 patients survived after risk-adapted therapy. High-risk patients seem to have benefited from intensified treatment that incorporated ifosfamide.

Influence of cosmetics on emotional, autonomous, endocrinological, and immune reactions.

Recent findings indicate that cosmetics increase positive valence of emotions and thereby influence the autonomous nerve system. Other studies showed the effects of emotions on the endocrinological and the immune system. Based on this preliminary conclusion, the aim of the present study was to prove whether cosmetics are able to decrease the level of the stress hormone cortisol and strengthen the immune system. Four slides of made up or unvarnished women each, integrated in another 16 slides each of equivalent valence and arousal, were presented to 60 women. During stimulus presentation, subjective (valence), autonomous (heart rate), endocrinological (salivary cortisol) as well as immunological reactions [secretory immunoglobulin A (sIgA)] were recorded. As expected subjective ratings concerning the slides of made up women reported more positive valence than those concerning unvarnished women. Furthermore, heart rate decreased under presentation of made up women, which indicates the positive influence of these slides on the autonomous nerve system. Furthermore, in half of the volunteers a decrease of cortisol and an increase of sIgA level while presenting the made up women was measurable in contrast to the presentation of unvarnished women. Maybe this is due to a short presentation time and the endocrinological as well as the immune system can be hardly influenced that quick. Another explanation could be that the volunteers were in part so called psychophysiological non-responders who show no reaction to emotional stimuli in the endocrinological and the immune system. It has to be considered that only the influence of visual stimuli and not the influence of social care (e.g. positive statements of other, etc.), which is normally connected with the use of cosmetics, was assessed, so that these delineated positive results show the lower limit of cosmetic effects.

Second malignancies after treatment for Ewing's sarcoma: a report of the CESS-studies.

PURPOSE: During recent years, more intensified systemic and local treatment regimens have increased the 5-year survival figures in localized Ewing's sarcoma to more than 60%. There is, however, concern about the risk of second malignancies (SM) in long-term survivors. We have analyzed the second malignancies in patients treated in the German Ewing's Sarcoma Studies CESS 81 and CESS 86. MATERIALS AND METHODS: From January 1981 through June 1991, 674 patients were registered in the two sequential multicentric Ewing's sarcoma trials CESS 81 (recruitment period 1981-1985) and CESS 86 (1986-1991). The systemic treatment in both studies consisted of a four-drug-regimen (VACA = vincristine, actinomycin D, cyclophosphamide, and adriamycin; or VAIA = vincristine, actinomycin D, ifosfamide, and adriamycin) and a total number of four courses, each lasting nine weeks, was recommended by the protocol. Local therapy in curative patients was either complete surgery (n = 162), surgery plus postoperative radiotherapy with 36-46Gy (n = 274), or definitive radiotherapy with 46-60Gy (n = 212). The median follow-up at the time of this analysis was 5.1 years, the maximum follow-up 16.5 years. RESULTS: The overall survival of all patients including metastatic patients was 55% after 5 years, 48% after 10 years, and 37% after 15 years. Eight out of 674 patients (1.2%) developed a SM. Five of these were acute myelogenic leukemias (n = 4) or MDS (n = 1), and three were sarcomas. The interval between diagnosis of Ewing's sarcoma and the diagnosis of the SM was 17-78 months for the four AMLs, 96 months for the MDS and 82-136 months for the three sarcomas. The cumulative risk of an SM was 0.7% after 5 years, 2.9% after 10 years, and 4.7% after 15 years. Out of five patients with AML/MDS, three died of rapid AML-progression, and two are living with disease. Local therapy (surgery vs. surgery plus postoperative irradiation vs. definitive radiotherapy) had no impact on the frequency of AML/MDS, but local therapy did influence the risk of secondary sarcomas. All three patients with secondary sarcomas had received radiotherapy; however, all three sarcomas were salvaged by subsequent treatment and are in clinical remission with a follow-up of 1 month, 4.3 years, and 7.5 years after the diagnosis of the secondary sarcoma. Thus far, SM contributed to less than 1 % (3/328) of all deaths in the CESS-studies. CONCLUSIONS: The risk of leukemia after treatment for Ewing's sarcoma is probably in the range of 2%. The risk of solid tumors also seems to be low within the first 10 years after treatment and remains in the range of 5 % after 15 years. In the CESS-studies, less than 1% of all deaths within the first 10 years after diagnosis were caused by SM. Effective salvage therapy for secondary sarcomas is feasible.

Radiotherapy in Ewing's sarcoma and PNET of the chest wall: results of the trials CESS 81, CESS 86 and EICESS 92.

PURPOSE: Treatment results and the pattern of relapse were evaluated in the multimodal treatment of Ewing's sarcomas of the chest wall. METHODS AND MATERIALS: In a retrospective analysis, 114 patients with non-metastatic Ewing's sarcoma of the chest wall were evaluated. They were treated in the CESS 81, CESS 86, or EICESS 92 studies between January 1981 and December 1993. The treatment consisted of polychemotherapy (VACA, VAIA, or EVAIA) and local therapy, either surgery alone (14 patients), radiotherapy alone (28 patients) or a combination of both (71 patients). The median follow-up was 46.6 months (range 5-170). A relapse analysis for all patients with local or combined relapses was performed. RESULTS: Overall survival was 60% after 5 years, event-free survival was 50%. Thirty-seven patients had a systemic relapse (32.4%), 11 patients had a local relapse alone (9.6%), and 3 patients had a combined local and systemic relapse (2.6%). The risk to relapse locally after 5 years was 0% after surgery alone, 19% after radiation alone, and 19% after postoperative irradiation. None of the 8 patients with preoperative irradiation have failed locally so far. With the introduction of central radiotherapy planning in CESS 86, local control of irradiated patients improved. Ten of 14 patients with local failure could be evaluated in the relapse analysis: 3 patients had an in-field relapse, 4 patients had a marginal relapse, 2 patients had a relapse outside the radiation fields, and 1 patient failed with pleural dissemination. Six treatment deviations were observed. CONCLUSION: Local control was best after surgery alone in a positively selected group of patients. Local control after radiation or combined radiation and surgery was good. With diligent performance of radiotherapy, it will be possible to further improve the results in the radiotherapy group.

Famotidine for infant gastro-oesophageal reflux: a multi-centre, randomized, placebo-controlled, withdrawal trial.

BACKGROUND: Gastro-oesophageal reflux afflicts up to 7% of all infants. Histamine-2 receptor antagonists are the most commonly prescribed medications for this disorder, but few controlled studies support this practice. AIM: To evaluate the safety and efficacy of famotidine for infant gastro-oesophageal reflux disease. METHODS: Thirty-five infants, 1.3-10.5 months of age, entered an 8-week, multi-centre, randomized, placebo-controlled, two-phase trial: first 4 weeks, observer-blind comparison of famotidine 0.5 mg/kg and famotidine 1.0 mg/kg; second 4 weeks, double-blind withdrawal comparison (safety and efficacy) of each dose with placebo. RESULTS: No serious adverse events were reported. Eleven patients had 16 non-serious, possibly drug-related adverse experiences: 6 patients with agitation or irritability (manifested as head-rubbing in two), 3 patients with somnolence, 2 patients with anorexia, 2 with headache, 1 patient with vomiting, 1 patient with hiccups, and 1 patient with candidiasis. Of the 35 infants, 27 completed Part I. There were significant score improvements for famotidine 0.5 mg/kg in regurgitation frequency (P = 0.04), and for famotidine 1.0 mg/kg in crying time (P = 0.027) and regurgitation frequency (P = 0.004) and volume (P = 0.01). Eight infants completed Part II on double-blind treatment, which was insufficient for meaningful comparisons. CONCLUSIONS: Histamine-2 receptor antagonists may cause agitation and headache in infants. A possibly efficacious famotidine dose for infants is 0.5 mg/kg (frequency adjusted for age). As 1.0 mg/kg may be more efficacious in some, the dosage may require individualization based on response. Further sizeable placebo-controlled evaluations of histamine-2 receptor antagonists in infants with gastro-oesophageal reflux disease are warranted.

Effect of MK-458 (HPMC) in Parkinson's disease previously untreated with dopaminergic drugs. A double-blind, placebo-controlled multicenter study.

Ninety-four patients with early Parkinson's disease were investigated in a double-blind, placebo-controlled evaluation of MK-458 [hydroxypropyl methylcellulose/lactose matrix (HPMC)], a sustained release formulation of a novel naphthoxazine compound with selective D-2 dopamine receptor agonism. Patients were previously untreated with dopaminergic drugs. Efficacy was assessed by clinical rating scales and by patient self-evaluation. MK-458 (HPMC) caused a significant decrease in most parkinsonian symptoms. Though disability rating scores were lowered by the drug, the scores did not differ significantly from placebo. However, statistically significant improvement occurred with MK-458 (HPMC) on both the physician and the patient global assessments. Adverse reactions such as nausea and vomiting, sedation, confusion, and hallucinations occurred more with MK-458 (HPMC) than with placebo. MK-458 (HPMC) possesses antiparkinsonian efficacy in early Parkinson's disease; however, side-effects are frequently associated with its use. Selective D-2 receptor agonists, such as MK-458 (HPMC), may not be the ideal treatment as monotherapy for Parkinson's disease.

Alexithymia and affective verbal behaviour of three groups of patients.

The study described in this article was designed to investigate patients' response to affective stimuli on two levels of measurement: one was designed to yield information about cognitive attribution processes whereas the second level was aimed at uncovering deeper, more unconscious responses to the given stimuli. These were displayed as part of an experimental setting, in which three groups were compared: psychosomatic (duodenal ulcer), somatic and psychoneurotic patients. Systematic variation was introduced by showing either of two versions of a short film which differed in the degree of friendliness displayed by the main character. The results show differential effects on the two levels of measurement: in the case of the first level, an interpretation within the framework of current conceptualizations of alexithymia would have been possible, but results for the second level of measurement (utilizing Gottschalk-Gleser content analysis of speech) indicate that psychosomatic patients show the same kind of sensitive response to affective stimuli as patients from the other two groups.

Coping strategies and defense mechanisms and their relevance for the recovery after discectomy.

Although several empirical studies have shown that psychological and social characteristics predict recovery after lumbar discectomy, the possible significance of the psychodynamic concept of defense mechanisms has been neglected. To investigate the predictive usefulness of defense mechanisms, coping strategies, and depression, 52 consecutive admissions were assessed before their operations and again six months later (n = 48). Using three outcome criteria, 8 patients (16, 7%) were classified as having poor operation outcomes. A stepwise discriminant analysis correctly classified 87.7% of these poor outcomes. The groups with poor and good outcome differed significantly in the prominence of two defense mechanisms: "rationalization" and "regression".

Predictors of bad and good outcomes of lumbar disc surgery. A prospective clinical study with recommendations for screening to avoid bad outcomes.

STUDY DESIGN: Patients were assessed by independent research teams in six different spine centers after indication for discectomy was established. Six- and twelve-month follow-ups were performed. OBJECTIVES: Objectives of this study were to determine somatic subjective symptoms, objective signs, sociodemographic, and psychological factors that influence the outcome of lumbar disc surgery, as well as to develop a screening checklist and score of reliable predictors to distinguish bad and good responders of surgery. METHODS: In addition to symptoms, signs, and neuroradiologic findings, sociodemographic data were obtained. A mobility questionnaire and Beck depression inventory were included in the structured interview. RESULTS: In all, 381 patients were examined. At 6 months 89% and at 12 months, 86% of all operated patients were available for follow-up study. There was no significant difference in the outcome between the 6- and 12-month follow-ups. Of the patients, 51.5% had a good outcome, 28.4% moderate, and 20.1% bad at 12 months follow-up. The calculation of predictor score gave an overall appropriate prediction of 80%, for good outcome 76%, and for bad 79%. CONCLUSION: In addition to clinical and radiologic examination, the Hannover Mobility Questionnaire, the Beck depression inventory, and structured interview should be included for preoperative assessment for disc surgery. If a bad outcome is predicted, it is probably more appropriate not to operate and await natural development of the disc disease or to apply conservative and psychological treatment.

Predictors of bad and good outcome of lumbar spine surgery. A prospective clinical study with 2 years' follow up.

STUDY DESIGN: Based on prospective assessment, patients with lumbar disc surgery were examined to determine reliable predictors for clinical outcome. OBJECTIVES: The prognostic value of a screening checklist developed in a previous study was evaluated in a 2-year follow-up. SUMMARY OF BACKGROUND DATA: Outcome studies of lumbar disc surgery document a success rate between 49-90%. It has been shown that a number of medical history data and sociodemographic and psychodiagnostic findings are of prognostic value for the outcome of lumbar spine surgery. METHODS: In addition to clinical and neuroradiologic examinations, 164 patients took part in a standardized interview. Eighty-two percent participated in a follow-up performed 2 years after the operation. Preoperative findings, outcome, and prediction of three diagnostic subgroups were compared. Eighty-three (51%) patients had disc herniation only, 29 (18%) had disc herniation and other relevant back diagnoses, and 51 (31%) had no disc herniation but had other relevant back diagnoses. RESULTS: In patients with disc herniation only, good results were observed in 53%, moderate in 19%, and bad in 28%. The accuracy of prediction of the postoperative result was 75% for the patients with good outcome and 86% for those with bad outcome. In the group of patients with diagnoses other than disc herniation, the success rate of the operation was 38% good, 28% moderate, and 41% bad, but the predictor score was not as useful as for the other groups. CONCLUSION: Patients with a high risk of a bad operation outcome after lumbar discectomy could be identified preoperatively. It is suggested that those patients take part in a pain management approach instead of or in addition to surgical intervention.

Gastric irritation of oxaprozin, a new nonsteroidal, antiinflammatory drug, in comparison to acetylsalicylic acid and indomethacin: a gastric potential difference analysis.

For the evaluation of gastric irritation of oxaprozin in comparison to indomethacin and acetylsalicylic acid, a study was carried out with eight healthy male volunteers, investigating doses of 600 and 1200 mg of oxaprozin compared to therapeutical equivalents of 50 mg indomethacin and 1000 mg acetylsalicylic acid. Gastric irritation was checked with the model of the transmural gastric potential difference. The model is based on the assumption that a change in electric tension caused by a lesion of the gastric mucosa, which leads to an increasing permeability of the cell membrane for electrolytes, is a sensitive parameter for cell disintegrity. The results of the study show that oxaprozin has less irritative potency than indomethacin and can thus be qualified as an antiinflammatory drug with a minimum of gastric irritation.

The effect of age on intervertebral disc compression during running.

Previous studies have shown that intervertebral discs compress under axial loading, yet few studies have examined the relationship between disc age and compressibility. The purpose of this study was to determine if the amount of vertebral column height (VCH) loss induced by running was significantly different between two age groups, 17 males ages 20-27 years and 14 males ages 50-57 years, who could comfortably run 6 miles. The subjects had no previous or current back pathologies. Within 1.5 hours of rising in the morning, each subject's VCH was measured from spinous processes C7 to S2. Immediately following the measurement, each subject ran a predetermined, paved, 6-mile course at a comfortable pace. Within minutes after completing the run, each subject was again measured for VCH. Paired t tests revealed significant decreases in VCH after the run in both groups. An independent t test showed no significant differences between the respective age groups in terms of postrun VCH decreases. Although no significant differences were noted between groups, this study has demonstrated that both age groups experienced significant decreases in VCH after a 6-mile run. These findings have implications for physical therapy for younger and older male patients who may have back pathologies and require an exercise program. Patients may be advised to limit running due to possible exacerbation of back symptoms.

Implementing a clinical pathway for congestive heart failure: experiences at a teaching hospital.

Clinical pathways are processes of care that use a multidisciplinary team effort to move patients toward a designed outcome. This article details the challenges of a Quality Enhancement and Clinical Resource Management Team in designing and implementing a successful congestive heart failure pathway at a teaching hospital. Academic institutions have the resources as part of their research mission, to enhance the development of clinical pathways and assess their outcomes.

Empirical study of alexithymia: methodology and results.

Starting with a review of selected examples of empirical studies on the concept of alexithymia, this paper then presents a new perspective that helps to integrate these diverse results. Studies are grouped into two types: those employing instruments (questionnaires, ratings) that directly assess alexithymia, and experimental studies. Studies of the first type are found to be inconclusive in that the search for a personality trait of alexithymia in psychosomatic patients has not been very fruitful. The evidence from experimental studies, however, does allow for some interesting interpretations: The apparent diversity in results can be resolved, if certain crucial dimensions are analyzed. On the stimulus side, interpersonal relevance and the degree of subjective involvement are found to be crucial, as results pointing towards alexithymia are mainly found when both of these are high. On the measurement side, large variations in results can be explained by reference to the "depth" of measurement level. On a more superficial or cognitive level, it is possible to find indications of alexithymia, whereas on a deeper, more unconscious level, psychosomatic patients' response to experimental stimuli are similar to that of controls. The implications of this are that alexithymia, rather than being understood as a personality trait, should be seen as a label for a set of coping behaviors that occurs in specific situations only.

Long-term efficacy and tolerability of rizatriptan wafers in migraine.

CONTEXT: Rizatriptan is a selective 5-HT1B/1D receptor agonist for the acute treatment of migraine. It is available in a unique wafer formulation that dissolves rapidly in the mouth and can be taken without liquids, thereby offering patients a very convenient way to take treatment. OBJECTIVE: To investigate the long-term efficacy of rizatriptan 10-mg and 5-mg wafers in migraineurs. SETTING: 19 headache clinics in 5 countries. PATIENTS: 458 patients diagnosed with migraine according to International Headache Society criteria. DESIGN: 6-month, open-label, extension, which followed a double-blind, placebo-controlled study. INTERVENTIONS: Patients were randomly assigned to 1 of 3 treatments for moderate or severe migraines: rizatriptan 10-mg wafer, rizatriptan 5-mg wafer, or "standard care" (usual migraine treatment -- eg, nonsteroidal anti-inflammatory drugs [NSAIDs], analgesics, other triptans). Patients randomized to rizatriptan were blinded to the dose. MAIN OUTCOME MEASURES: Headache severity (none, mild, moderate, severe) and adverse events were recorded on a diary card. RESULTS: 181 patients treated 3393 attacks with rizatriptan 10-mg wafer, 191 treated 3254 attacks with rizatriptan 5-mg wafer, and 86 treated 1582 attacks with standard care. The median number of treated attacks per patient was 16 for rizatriptan 10-mg wafer, 13 for rizatriptan 5-mg wafer, and 14 for standard care. The median patient on rizatriptan 10-mg wafer reported pain relief at 2 hours (reduction of headache from moderate or severe at baseline to mild or none) in 82% of attacks, vs 73% of attacks for standard care (odds ratio [95% confidence interval] = 1.63 [1.14, 2.34], P <.01) and 72% of attacks for rizatriptan 5-mg wafer (OR [95% CI] = 1.60 [1.23, 2.08], P <.001). The median patient on rizatriptan 10-mg wafer was pain free at 2 hours in 46% of attacks, vs 30% of attacks for standard care (OR [95% CI] = 1.50 [1.06, 2.12], P <.05) and 25% of attacks for rizatriptan 5-mg wafer (OR [95% CI] = 1.93 [1.50, 2.49], P <.001). All treatments were generally well tolerated. Compared with standard care, rizatriptan 5-mg wafer was associated with fewer specific adverse events of asthenia/fatigue, back pain, nausea, pharyngeal discomfort, upper respiratory infection, and vomiting (P values <.05), and, compared with rizatriptan 10-mg wafer, fewer overall drug-related adverse events (P <.05). CONCLUSIONS: Rizatriptan 10-mg wafer was more effective than standard care and rizatriptan 5-mg wafer for treating intermittent moderate or severe migraine attacks occurring over periods of up to 6 months. Rizatriptan wafers were well tolerated.

Standardized teaching plans in the ambulatory laser center.

The changing economic climate in health care has motivated nurses to clearly define their role and job duties. Ophthalmic nurses, in particular, have to relate to the differences between the skill level of nurses and technicians. Staff nurses asked to define their role in an ambulatory ophthalmic laser center, placed a high priority on patient education as a professional responsibility. Their view is supported by the Joint Commission Accreditation Manual for Hospitals, and is listed as a responsibility for the registered nurse by that agency. The Joint Commission Standards were reviewed, and a review of related theories of learning was conducted. Teaching standards were developed for nine ophthalmic laser procedures. The standards include teaching content and appropriate teaching aids. The goal is to inform patients specifically regarding the laser surgery, and eye health in general. The patient's knowledge base regarding laser surgery is addressed as part of the nursing assessment and documented in the progress note. Information regarding the proposed procedure is provided based on the teaching standard, and the patient's level of understanding is documented in the progress note. Theories of learning as well as individual teaching standards and tools will be presented.

[Incidence and prevalence of type 2 diabetes mellitus in Germany: an analysis based on 5.43 million patients]. / Inzidenz und Prävalenz von Diabetes mellitus Typ 2 in Deutschland.

BACKGROUND AND OBJECTIVE: Based on claims-data of 5.43 million members of a large German statutory health insurance fund in 2008 (Techniker Krankenkasse), the aim of this contribution is to update and more precisely quantify age- and gender-specific prevalence and incidence of type 2 diabetes mellitus (T2DM) in a German setting. METHODS: A patient was classified as T2DM prevalent if he or she had received at least two outpatient diagnoses of T2DM in two different quarters of the year and/or had received at least one T2DM diagnosis during inpatient treatment between 01/01/2006 and 12/31/2008. A patient was considered to have had new onset T2DM in 2008 under one of three conditions: 1. no diagnosis of T2DM in 2006 and 2007, 2. no presripction of oral antidiabetics in 2006 and 2007, 3. either one inpatient or two outpatient diagnoses of T2DM conducted in two different quarters of 2008 or one outpatient T2DM diagnosis in 2006/07 when the second diagnosis was made in 2008. RESULTS: A total of 254,524 patients had T2DM. Compared to the total membership of the medical insurance fund, the prevalence of T2DM was 4.69 %. The average age was 64.8 years, and 66.37 % were male. The incidence of T2DM in our sample was 2.814 cases per 1,000 person-years in men and 1.690 cases in 1,000 person-years in women. Based on our sample and on official population data, 4,704,585 patients (5.75 %) in Germany would be T2DM prevalent in 2009. The number of incident T2DM cases would amount to 215,746 patients (0.264 %). CONCLUSIONS: T2DM is one of the most common chronic diseases in Germany. The expected demographic changes in Germany will increase the burden on the German health system caused by T2DM.

[Pharmacoeconomic studies - usability for reimbursement decisions]. / Pharmakoökonomische Studien - Nutzbarkeit für leistungsrechtliche Entscheidungen.

BACKGROUND AND OBJECTIVE: In Germany, cost-benefit-assessments are incorporated by law since April 2007. In this study it is examined whether published international pharmacoeconomic studies correspond to the methodological recommendations of the Institute for Quality and Efficiency in Health Care (IQWiG) and international guidelines, and whether they are usable for reimbursement decisions. METHODS: Pharmacoeconomic studies were identified by a systematic literature review and compared with the requirements of the IQWiG and 15 other international institutions. In hypothetical selection processes it was examined which and how many studies could be considered as basis for reimbursement decisions. RESULTS: 130 out of 1,982 pharmacoeconomic studies were identified as relevant and analyzed. Most frequently, the USA was mentioned as reference country (41 %) prior to UK (15 %), Canada (6 %) as well as Japan and Germany (each 4 %). In 63 % standard therapy was chosen as comparator. In 60 % of studies the payer's perspective was chosen primarily, in 22 % the societal perspective. Two thirds of the studies were modeled in most parts. Only two studies performed a comparison with standard therapy from the perspective of the statutory health insurance and could have been considered for reimbursement decisions of the G-BA. Only one German study examined the real-life effectiveness and compared it to standard therapy. CONCLUSIONS: The study revealed a congruence between the methods of iqwig and other similar international institutions. However, hitherto existing pharmacoeconomic studies do not follow international and German guidelines in many points. In consequence IQWiG will have to perform the analyses itself and the assessment process will be time-consuming and tedious so that in the short and medium term no relevant cost savings can be expected.