[Primary Immunodeficiency: Primary Antibody Disorders in Respiratory Medicine]. / Primäre Immundefekte: Antikörpermangelerkrankungen in der Pneumologie.

Clinical manifestations of primary immunodeficiency are heterogeneous, and early diagnosis is challenging. Leading symptoms are recurrent upper and lower respiratory tract infections. Response to antibiotic therapy is often reduced. Beside infectious complications autoimmunity, autoinflammation and malignant diseases occur frequently. About 50 % of all PID patients are diagnosed after childhood, and the main group are patients with primary antibody deficiencies. Treatment of choice is the immunoglobulin substitution and the prophylactic or therapeutic use of antibiotics. In patients presenting with immunodysregulation, immunosuppression is additionally indicated. Especially due to recurrent lower airway infection and/or interstitial lung diseases PID patients have a decreased live expectancy. Hence, both early diagnosis and sufficient therapy are mandatory.

Treatment strategies in patients with AML or high-risk myelodysplastic syndrome relapsed after Allo-SCT.

Non-relapse mortality after Allo-SCT has significantly decreased over the last years. Nevertheless, relapse remains a major cause for post SCT mortality in patients with AML and high-risk myelodysplastic syndrome (MDS). In this retrospective single-center analysis, we have analyzed the treatment outcomes of 108 patients with AML or MDS, who relapsed after Allo-SCT. Seventy of these patients (65%) were treated with salvage therapies containing chemotherapy alone, allogeneic cell-based treatment or the combination of both. Thirty-eight patients (35%) received palliative treatment. Median OS after diagnosis of relapse was 130 days. Compared with patients who received chemotherapy alone, response to salvage therapy was significantly improved in patients treated with a combination of chemo- and allogeneic cell-based therapy (CR rate 57% vs 13%, P=0.002). Among risk factors concerning pretreatment characteristics, disease status before first Allo-SCT, and details of transplantation, only the time interval from Allo-SCT to relapse was an independent predictor of response to salvage therapy and OS. These data confirmed that time to relapse after transplantation is an important prognostic factor. Up to now, only patients eligible for treatment regimens containing allogeneic cell-based interventions achieved relevant response rates.

Incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in renal transplant recipients.

In this descriptive cross-sectional study, we investigated the incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in 150 adult renal transplant recipients with more than one year posttransplant status. Symptom frequency and symptom distress, and self-care agency were measured by the Transplant Symptom Frequency and Symptom Distress Scale, and the Appraisal for Self-Care Agency Scale, respectively. The Long-Term Medication Behavior Self-Efficacy Scale and a renal transplant knowledge questionnaire were developed as part of this study to measure perceived self-efficacy and knowledge of the therapeutic regimen. Demographic variables were also measured. The incidence of subclinical noncompliance with immunosuppressive therapy as assessed by interview was 22.3%. Compliers and noncompliers differed significantly on the variables of marital status (P = 0.03), situational-operational knowledge (P = 0.02), self-care agency (P = 0.03), and perceived self-efficacy related to long-term medication intake (P = 0.048). A logistic regression model using gender, marital status, perceived self-efficacy, self-care agency, knowledge about medication administration and signs of infection, and situational operational knowledge as predictor variables, revealed a 78.6% correct classification of compliers versus noncompliers and a sensitivity ratio of 95.9%. There were significantly more acute late rejection episodes (P = 0.003) in the noncompliant group. Graft survival at 5 years in this group was also significantly lower (P = 0.03) than the compliant patients. No significant difference was found in terms of the occurrence of chronic rejection episodes or in terms of patient survival at 5 years. Because noncompliance is a risk factor for negative clinical outcome in renal transplant recipients, it is of utmost importance to develop intervention strategies to enhance compliance in this population by using determinants identified in exploratory studies.

Late acute rejection and subclinical noncompliance with cyclosporine therapy in heart transplant recipients.

BACKGROUND: Although noncompliance with immunosuppressive medication is recognized as a critical behavioral risk factor for late acute rejection episodes and graft loss after transplantation, little is known about the degree of subclinical cyclosporine noncompliance, its associated risk for acute late rejection episodes (>1 year after transplantation), and its determinants in heart transplant recipients. METHODS: The convenience sample of this longitudinal study included 101 European heart transplant recipients (87 men and 14 women), with a median age of 56 (Q1 = 50, Q3 = 61) and a median posttransplantation status of 3 (range 1 to 6) years. Subclinical cyclosporine noncompliance was measured during a 3-month period with electronic event monitoring. Selected sociodemographic, behavioral, cognitive, emotional, health, and treatment-related determinants of medication noncompliance were measured by using instruments with established psychometric properties or by patient interviews. With the use of iterative partitioning methods of cluster analysis, including nonstandardized electronic event monitoring compliance parameters, patients were categorized by degree of subclinical cyclosporine noncompliance into a 3-cluster solution. RESULTS: Overall compliance was high, with a median medication taking compliance of 99.4%. The 3 derived clusters, that is, excellent compliers (84%), minor subclinical noncompliers (7%), and moderate subclinical noncompliers (9%), differed significantly by degree of subclinical noncompliance (p < .0001) and showed a 1.19%, 14.28%, and 22.22% incidence of late acute rejections (p = .01), respectively. The 3 groups also differed in terms of former medication noncompliance (p = .02), appointment noncompliance (p = .03), and perceived self-efficacy with medication taking (p = .04). CONCLUSIONS: Although in absolute numbers cyclosporine compliance in this sample was high, minor deviations from dosing schedule were associated with an increased risk for acute late rejection episodes. This suggests a pivotal role of patient compliance in successful long-term outcome after transplantation.

Bioequivalence study of two morphine extended release formulations after multiple dosing in healthy volunteers.

AIM: Two extended release (ER) formulations of morphine sulphate (30 mg each), Oramorph SR (test) and a marketed reference formulation (MST Mundipharma Retardtabletten), were investigated for their relative bioavailability at steady-state: METHODS: The study was designed as a single-centre, open-label, two-period crossover, pharmacokinetic comparison in 28 healthy male volunteers and was completed in 23 subjects. The determination of morphine and its metabolite morphine-6-glucuronide in plasma was done by HPLC with electrochemical detection after solid-phase extraction. RESULTS: Under steady-state conditions in the first dosing interval, mean maximum plasma concentrations for morphine were 19.1 ng/ml (CV% 41) for Oramorph SR 30 mg and 19.1 ng/ml (CV% 33) for MST-30 Mundipharma Retardtabletten. Geometric mean AUC(0-12) values were calculated as 108 ngxh/ml (CV% 40) for Oramorph SR 30 mg and as 118 ng x h/ml (CV% 30) for the reference formulation. The plasma concentrations of the major metabolite, morphine-6-glucuronide, were found to be generally in a higher range compared to the parent compound. The 90% confidence intervals of test to reference ratios calculated for all relevant parameters (AUC, C(max), PTF) for both the parent compound and morphine-6-glucuronide were all within the limits of 80 - 125%. The most frequent adverse events (AE > 10%) during Oramorph SR 30 mg treatment were headache (36%), dizziness (18%), nausea (21%), vomiting (21%) and pruritus (11%). During treatment with MST-30 Mundipharma Retardtabletten, the most frequent AEs were headache (29%), dizziness (13%), nausea (29%) and vomiting (29%). CONCLUSION: The results demonstrate bioequivalence of Oramorph SR 30 mg and MST-30 Mundipharma Retardtabletten.

Bioavailability and selected pharmacokinetic parameters of clindamycin hydrochloride after administration of a new 600 mg tablet formulation.

The study was conducted to investigate the pharmacokinetics and relative bioavailability of clindamycin after administration of two oral clindamycin HCl formulations. A new tablet preparation containing 600 mg clindamycin (Clinda-saar 600, test) was compared to a marketed capsule containing 300 mg clindamycin (Sobelin 300, reference). Both preparations revealed comparable in vitro dissolution profiles with high batch conformity and homogeneity. Twenty healthy male volunteers received single doses of 600 mg clindamycin (test: 1 tablet, reference: 2 capsules) in an open, randomized, two-period crossover design. Blood samples were drawn up to 14 h p.a. and clindamycin plasma concentrations were measured using a sensitive and specific HPLC-UV method. Pharmacokinetic characteristics were similar for both preparations, arithmetic mean values (standard deviation) were computed as: AUC(0-infinity) 12.2 (4.2) and 13.1 (4.6) microg x h/ml, Cmax 3.1 (0.8) and 3.4 (0.8) microg/ml, t(max) 0.83 (0.24) and 0.85 (0.34) h, t(1/2) 2.3 (0.4) and 2.3 (0.6) h for test and reference, respectively. Mean relative bioavailability (point estimate) was 93% for AUC and 91% for Cmax. 90% confidence intervals for AUC and Cmax were within the predefined bioequivalence acceptance limits. Bioequivalence of test and reference preparations could be demonstrated. Single doses of 600 mg clindamycin orally were well tolerated without relevant differences between both preparations.

Beyond the Role of ExtenderIndependent and Interdependent Contributions of Nursing to Geriatric Rehabilitation.

Too often, the role of nursing in geriatric neurorehabilitation is defined in terms of extending the care of other disciplines and assuring continuity of selected aspects of care over 24 hours. This article argues that nursing has made significant clinical and scientific progress in contributing, independently and interdependently, to quality rehabilitation care for older adults; and that the role of nursing clearly exceeds the realm of mere extension and continuity of care. Reviewed are nursing's innovations in the areas of promoting comprehensive assessment; fostering functional independence, self-care, and self-care agency; enhancing communication; encouraging family involvement; improving cognitive status; and assuring quality physical care. We conclude with a discussion of the relationship of nursing to other disciplines, and how nursing's contributions can be optimized within the broader context of multidisciplinary geriatric rehabilitation.

Case study of quality assurance in the administration of chemotherapy.

The purpose of the study was to monitor the quality of chemotherapy administration within the department of oncology, of the university hospitals in Leuven (Belgium), by focusing on prescription and documented administration of chemotherapy. First, the actors and phases of the process were identified. Then selected patient records of three different types of chemotherapy were retrospectively analysed for 453 chemotherapy administrations. Study results indicated an important need to standardize the nursing and medical guidelines concerning chemotherapy administration. A formal task force was established to work on a multidisciplinary basis. The goals were to improve the routine process by identifying practical problems at any level and to standardize procedures by replacing all poorly defined "habits" by well-structured guidelines.

Frequency of intravenous medication administration to hospitalised patients: secondary data-analysis of the Belgian nursing minimum data set.

The purpose of this study was to investigate the frequency of intravenous medication administration with Belgian hospitalised patients. Factors, which might influence this frequency of administration, were also studied. Research questions were investigated by secondary data-analysis of the Belgian Nursing Minimum Data Set. The randomised sample consisted of 1,035,681 observations on 421,530 patients. Results of this study demonstrate that one out of three (34%) hospitalised patients received intravenous medication. Medical diagnoses, for which most intravenous medications were administered, were oncological diseases: myeloid (77.9%) and lymphoid (69.4%) leukaemia. Elderly (6.7%) and female (31.2%) patients received significantly less intravenous medication than respectively young (32.9%) (chi(2) = 98411, df = 1, p<0.001) and male (38%) (chi(2) = 2033, df = 1, p<0.001) patients. Patients with intravenous medication administration were labour intensive for nursing staff.

Determinants of pain assessment by nurses.

In this replication study pain assessment and patient perception by nurses was studied in relation to patient characteristics and nurse characteristics. Nurses were randomly assigned to one of 24 descriptions of a hypothetical patient of constant age and unspecified sex. The 24 descriptions varied by duration of pain, presence of a physical pathology, diagnosis category, and depression symptoms. Results showed that third- and fourth-year student nurses of a hospital based program, and registered nurses attributed more pain when test results of physical pathology were positive. Third- and fourth-year student nurses also attributed more pain to depressive patients. No differences were found with respect to pain duration and diagnostic category. Nursing experience seems also to be important in pain assessment. First-year student nurses attributed less pain to the hypothetical patient than third- and fourth-year student nurses and registered nurses. In addition they perceived the patient as more positive when physical pathology was present or when no symptoms of depression were present.

Nurses' attitudes toward pain treatment with opioids: a survey in a Belgian university hospital.

AIM: To investigate nurses' attitudes toward pain treatment with opioids in a Belgian university hospital. METHOD: A cross-sectional, descriptive study design was used. The randomised sample included 350 nurses working in the University Hospital Leuven, Belgium. Non-response was 10.9%. Nurses' attitudes were explored by a structured questionnaire. The score on the opioid attitude scale (OAS) varied between 9 and 45. RESULTS: Despite a neutral to positive score on the OAS (mean=69.4%), nurses had clearly negative attitudes towards the use of opioids during a diagnostic phase and the risk of possible addiction. These negative attitudes can hinder adequate pain treatment.

Nurses' smoking worldwide. A review of 73 surveys on nurses' tobacco consumption in 21 countries in the period 1959-1988.

Nurses are the largest professional group in health care. Nurses' smoking is not only important to their personal health, but also to the public's health. Analysis of smoking prevalences found among nurses in 21 countries in the period 1959-1988 shows that considerable numbers of both female and male nurses are smokers. More often than not there are found as many smokers among nurses as among the general population, sometimes even more. Only in Canada and Finland female nurses smoked clearly less than the population at large. Nurses' smoking prevalences decreased slowly in industrialized countries. An exemplary role is recognized by many nurses; more so by non-smoking nurses than by their smoking colleagues. Factors influencing nurses' smoking are professional socialization, duality of roles, workstress, discrepant expectancies about nurses' role and lack of social support. Theoretical explanations for nurses smoking by means of the theories of strain, of selection, of social control and of professional subculture are discussed. Future research should be internationally coordinated and aimed at comparability within a cultural and organizational context.

Cross-cultural testing of the "appraisal of self-care agency: ASA scale" in Norway.

The purpose of this study was to test the discriminant validity and interrater reliability of an instrument that measures aspects of self-care agency using Norwegian populations. The ASA scale forms A and B, which had been tested in the Netherlands previously, were translated into Norwegian and administered to two groups of elderly subjects and to a sample of geriatric nurses and nursing assistants in Norway. The subjects, one group from two geriatric rehabilitation units, and another from those living independently who were attending activity centres, completed the ASA-A scale. The nurses filled out the ASA-B scale. The results were supportive of the validity and reliability. Discriminant validity of the ASA scales was demonstrated.

Validity testing of the Dutch translation of the appraisal of the self-care agency A.S.A.-scale.

The purpose of this study was translation and construct validity testing of the appraisal of the self-care agency ASA-scale. This scale measures operability of self-care agency. The original English version of the scale was translated into Dutch. Subsequently the Dutch version was retranslated into English and compared with the original for semantic and cross-cultural differences. Construct validity of the translated scale was tested on 140 elderly in the Netherlands. The scale was administered to 40 randomly selected patients of a nursing home, 30 residents of a personalized care facility, 30 residents of a service flat and 40 randomly selected elderly who lived independently in the adjacent community. As hypothesize, mean ASA scores of the four groups of elderly differed significantly. The less dependent on institutionalized nursing care the higher the operability of the self-care agency scores of the elderly.

Conditions, interventions, and outcomes in nursing research: a comparative analysis of North American and European/International journals. (1981-1990).

This study compared the conceptual foci and methodological characteristics of research projects which tested the effects of nursing interventions, published in four general nursing research journals with predominantly North American, and two with predominantly European/International authorship and readership. Dimensions and variables of comparison included: nature of subjects, design issues, statistical methodology, statistical power, and types of interventions and outcomes. Although some differences emerged, the most striking and consistent finding was that there were no statistically significant differences (and thus similarities) in the content foci and methodological parameters of the intervention studies published in both groups of journals. We conclude that European/International and North American nursing intervention studies, as reported in major general nursing research journals, are highly similar in the parameters studied, yet in need of overall improvement. Certainly, there is no empirical support for the common (explicit or implicit) ethnocentric American bias that leadership in nursing intervention research resides with and in the United States of America.

A summer institute on computer applications for nursing management: background, curriculum, and evaluation.

Nursing managers are faced with a growing number of computer applications for nursing management, yet they may lack the educational preparation to assist them in using these technologies for problem-solving and decision-making. This article describes a Summer Institute on informatics applications for nursing management taught by an international and multidisciplinary team of faculty members, and offered at the University of Limburg (Maastricht, The Netherlands). A discussion of professional, scientific, and educational issues serves as the foundation for curriculum content and instructional format. Evaluation data from both offerings are reviewed and underscore the professional relevance and didactic quality of the Summer Institute. The Summer Institute is presented as a possible model of continuing education in computer applications for nursing management transferable to Western European and North American countries.

[Clinical nursing research. New standards for quality assurance for nursing and patient]. / Klinische Pflegeforschung. Eine neue Qualitätssicherung für Pflege und Patient.

Nursing as a health-service has a long tradition, nursing research however, a relatively short history. Florence Nightingale was the first to publish about nursing research in the year 1858. Since Nightingale, the need to study and improve the efficacy and efficiency of nursing has steadily increased. More than ever before, society needs nursing based on scientific knowledge and not just on unchallenged rituals and traditions. This scientific knowledge base can be acquired by clinical research. Within multidisciplinary clinical research it is necessary to focus on nursing's unique function. Virginia Henderson (1955) and Dorothea Orem (1959) have clearly explicated this function. Designs for clinical nursing research can be (quasi-) experimental, correlational or descriptive. Descriptive research can be qualitative or quantitative. Effects of nursing interventions on decrease of self-care problems and improvement of self-care capability and behaviors, should be investigated by experimental or quasi-experimental studies. Some examples of clinical nursing research are given. The first example demonstrates the effect of quantity and quality of nursing staff on patient's capabilities for hygiene self-care. The second example explicates the relation between self-care and quality of life with breast-cancer patients under chemotherapy treatment. The last example shows the effect of diabetes education on self-care behaviour and metabolic control. The examples given demonstrate the importance of clinical research focused on nursing's unique function. In order to accomplish this, programs of research are needed as well as close co-operation with nursing services, physicians and hospitals. Only when research findings are discussed and implemented in multidisciplinary teams, nursing will become more evidence-based.

[The influence of nursing measures on incision pain and the use of opioids in the postoperative period]. / Der Einfluss pflegerischer Massnahmen auf Inzisionsschmerz und Opioidverbrauch in der postoperativen Phase.

This experimental study was designed to investigate the influence of a cognitive behavioural technique on elective abdominal-surgical and orthopaedic patients at seven different time points within the first 72 postoperative hours. It examines the effect of deep breathing relaxation on the anxiety, distress, and incisional pain levels of postoperative surgical patients. The results show that the cognitive behavioural technique positively affects postoperative perception of pain, energy level, relaxed state and strain within the experimental group. The technique did not influence the patients' postoperative state-anxiety and agitation. Postoperatively, patients from the experimental group in both surgical areas used more opioids than patients from the control group. Preoperatively assessed personality factors did not differ between both groups. Overall the findings suggest that the implementation of a deep breathing relaxation technique positively influences the postoperative course of elective abdominal-surgical and orthopaedic patients.

[Frequency of oral hygiene nursing in cancer patients in Belgian hospitals. Frequency of nursing interventions and indicators]. / Häufigkeit von Mundpflege bei Krebspatienten in belgischen Krankenhäusern. Häufigkeiten pflegerischer Interventionen und Indikatoren.

This article describes the frequency of mouth care for cancer patients in Belgian hospitals. It also analyses the indicators used for this specific type of compensatory nursing care. The study was designed as a secondary data analysis of the 1990 Belgian Nursing Minimum Data set. The randomised sample included 35,347 oncology patients. Frequency of mouth care was 10.3%. The most important indicators were ventilation (70.58%), nasogastric tube (55.01%), endotracheal tube (43.17%), isolation of the patient (40.57%), malignant neoplasmas of lip, cavity and pharynx (40.21%), age younger than 8 years (37.06%) and disorientation of the patient (31.49%). Frequency of mouth care increased with a higher qualification of staff and higher staffing ratios.

[Incidence and prevalence of postoperative acute confusion in heart surgery patients after coronary artery bypass and heart valve replacement surgeries]. / Inzidenz und Prävalenz postoperativer akuter Verwirrtheit kardiochirurgischer Patienten nach Bypassoperationen sowie Herzklappenersatz.

Compared to foreign countries, Germany does not have data about the occurrence of acute confusion following heart-surgery. However, the occurrence of acute confusion does extend the hospital length of stay for up to 13 days. Thus, this phenomenon is of high relevance to nursing. This prevalence/incidence study was implemented with the goal of obtaining exact information on the incidence rate of acute postoperative confusion after a heart surgery through a multicenter evaluation. The data evaluation took place in the form of a convenience sample survey in three different German clinics specializing on heart surgeries. The observation period lasted from the day of the surgery up to the fifth postoperative day. In the context of this prospective Cohort-study all patients aged 18 and older who had heart surgery between February 1st and April 30th, 2000, were considered suitable as participants in the study. In the end, 860 patients were included in this study. 152 patients (17.4%) showed symptoms of acute confusion (confidence interval 14-20%). Certain circumstances seemed to predispose patients to acute confusion. A widespread occurrence could be observed particularly at night. Patients aged 81-91 were mainly affected. A confusion rate of 43.5% could be determined for this group. These results confirm the clinical importance and suggest interdisciplinary approaches for solution.