[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.

Bowel management in patients with spinal cord injury -- a multicentre study of the German speaking society of paraplegia (DMGP).

STUDY DESIGN: A descriptive, cross-sectional, multicentre design was used. OBJECTIVE: To analyse bowel management in patients with spinal cord injury (SCI) especially the occurrence of unplanned bowel evacuations and duration of planned bowel evacuation. SETTING: In total, 29 rehabilitation facilities for SCI patients in Austria, Germany, the Netherlands and Switzerland, with a total of 837 hospitalized SCI patients. METHOD: Data were collected by nurses within 1 week in November 2001 using a quantitative questionnaire containing 14 questions. For data analysis, a chi (2)-test was used for differences in the outcome of bowel evacuation procedures associated with different interventions. Stepwise multiple logistic regression was used to analyse the relationship between the outcome of bowel management and the interventions as well as intervening factors. RESULTS: More unplanned bowel evacuations were associated with usage of oral laxatives (n=444, P<0.001) as well as bowel evacuation every day (n=270, P<0.05) or every second day (n=368, P<0.05). The outcome of less unplanned bowel evacuations was associated with manual removal of stool combined with digital stimulation (n=35, P<0.05) and spontaneous bowel evacuations (n=104, P<0.001). Short duration of bowel evacuation (<60 min) was associated with manual removal of stool (n=64, P<0.05), the sitting position at defecation (n=494, P<0.001) and low frequency of bowel evacuation (>or=3 days) (n=638, P<0.05). Duration >60 min was associated with the use of oral laxatives (n=444, P<0.001) and complete loss of sensory function (n=349, P<0.05). Stool of hard consistency was associated with the manual removal of stool (n=64, P<0.001), the manual removal of stool in combination with digital stimulation (n=53, P<0.001) and the sitting position at defecation (n=494, P<0.05). Stool of soft consistency (n=341) was associated with the complete motor lesion (n=443, P<0.05). CONCLUSION: Manual removal of stool was combined with low risk of unplanned bowel evacuations and short duration of evacuation time. These results are useful to improve the outcomes of bowel management in SCI patients.

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.

[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.

The dialysis diet and fluid non-adherence questionnaire: validity testing of a self-report instrument for clinical practice.

This study evaluated the validity of the dialysis diet and fluid non-adherence questionnaire (DDFQ) as a self-report instrument for clinical practice. The DDFQ was designed to measure non-adherence behaviour with diet and fluid guidelines in patients treated with hospital-based haemodialysis in Flanders (Belgium). In a multicentre cross-sectional study design, 564 patients from 10 dialysis centres in Flanders completed the DDFQ Criterion and construct validity of the instrument were substantiated using correlation techniques between the DDFQ and biochemical and biological ratings of non-adherence. The results of this study suggest that the DDFQ is a valid self-report instrument to assess non-adherence behaviour in haemodialysis patients in Flanders and probably also in other cultures.

[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.

Frequency of and indications for wholly compensatory nursing care related to enteral food intake: a secondary analysis of the Belgium National Nursing Minimum Data Set.

This study describes the frequency of and indications used for total feeding assistance and tube feeding in a national representative sample of Belgian hospital patients (n = 421 314). Data from the 1990 national minimum nursing data registration was used. Orem's self-care model was used to describe and categorize types of nursing care and related indications. The scope of wholly compensatory nursing care was limited to total feeding assistance and tube feeding. This type of nursing care is indicated when self-care agency is undeveloped or cannot be used and when self-care demands are significantly increased. Based on review of the literature, hypotheses to indicate nursing care were formulated and tested. Wholly compensatory nursing care related to enteral food intake is given to 14.4% of the total patient population in Belgian hospitals. If self-care demand increases due to malnutrition, then this is an indication for total feeding assistance. If self-care agency decreases due to blindness, mental retardation, disorientation or upper extremity dysfunction, then this is also an indication for total feeding assistance. If self-care agency decreases due to impaired chewing, then this is an indication for tube feeding. This study has generated the first representative national nursing statistics about total feeding assistance and tube feeding in hospitals.

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.

[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.

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.

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.

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.

Bioavailability study of two carbamazepine containing sustained release formulations after multiple oral dose administration.

Carbamazepine (CAS 298-46-4), an iminostilbene derivative and a structural congener of the tricyclic antidepressant drugs, has been used in the treatment of epileptic seizures since 1963. The bioavailability/bioequivalence of a carbamazepine sustained release formulation (Timonil retard) was compared with a reference formulation in an open 2-period crossover study in 21 healthy male volunteers (including 1 drop-out) after multiple dose administration. During a run-in phase of 6 days the daily dose was gradually increased from 100 to 400 mg. On days 9 to 15, either the test or the reference formulation was administered twice daily, followed by a switch of preparation for a further 7 days of treatment (days 16 to 22). On the pharmacokinetic profiling days 15 and 22 blood samples were drawn over a 24-h period. In addition, blood samples were withdrawn before morning administrations for determination of carbamazepine and carbamazepine-10,11-epoxide trough values. Plasma concentrations of carbamazepine and its metabolite carbamazepine-10,11-epoxide were determined using a specific and sensitive HPLC method with UV detection. The results showed that autoinduction of carbamazepine metabolism under the chosen dosage regimen was complete within 14 days after start of treatment and that the criteria for bioequivalence were met. The 90% confidence intervals of all ratios were included by a range of 80-125% (AUC0-12: 103-120; AUC12-24: 105-119; Cmax0-12: 104-118; Cmax12-24: 104-118). During the study, 12 subjects experienced a total of 24 adverse events with mild to moderate intensity. Due to a significant increase of liver enzyme activity in serum during the course of the study, one subject was excluded from further study participation. There were no serious adverse events. It was concluded that the test formulation is bioequivalent to the reference formulation with respect to rate and extent of absorption.

Pseudo-opioid-resistant pain.

The purpose of this article is to describe and analyse factors that result in pseudo-opioid-resistant pain. This is defined as a persistent pain experience communicated by the patient or family after prescription and initiation of opioid therapy based on empirically validated criteria. Pseudo-opioid-resistant pain can be caused by inadequate self-care or family care in relation to opioid therapy. Problems can arise in relation to communication of the pain experience, acceptance of the treatment choice and correct opioid administration. These problems may result from misconceptions or knowledge deficit, lack of motivation and lack of performance capabilities. The article systematically analyses the three categories of aetiological factors and arrives at a comprehensive explanatory model. This can be used for research purposes as well as for problem detection in clinical practice. The article includes a case report.

Muscle weakness is related to utilization of health care resources in COPD patients.

The factors determining utilization of health care resources in patients with chronic obstructive pulmonary disease (COPD) are poorly understood. In order to obtain insight into these factors, we studied the utilization of health care resources in 57 stable COPD patients with a forced expiratory volume in one second (FEV1) of 36 +/- 9% predicted. Patients were divided into two groups: admitted at least twice in the last year (high medical consumption; n = 23) or not admitted in the last year (low medical consumption; n = 34). Other variables related to utilization of health care resources studied were; the number of hospital days; the number of out-patient visits to a pulmonary department in the last year; and the average daily dose (ADD) of corticosteroids taken in the last 6 months. The actual cost of utilization of health care resources, however, was not studied. In addition, pulmonary function, serum electrolytes, blood gas values, 6 min walking distance, respiratory and peripheral muscle force, and appraisal of self-care agency (ASA score) were studied. Pulmonary function, serum electrolytes, blood gas values, ASA score and walking distance were not different between the two groups (e.g. FEV1 36 +/- 8 vs 36 +/- 10% pred). Respiratory muscle forces tended to be lower in the high medical consumption group, this tendency almost reaching statistical significance for maximal expiratory pressure (PE,max) (p = 0.08). Peripheral muscle force, however, was clearly reduced in the high medical consumption group (quadriceps force 63 +/- 20 vs 82 +/- 26% pred; p < 0.05). The number of admissions, the number of hospital days, the number of out-patient visits, and ADD were interrelated and also related to ventilatory and peripheral muscle force (r -0.18 to -0.38). This relationship was statistically significant for PE,max, whilst a similar tendency was present for maximal inspiratory pressure (PI,max). In stepwise multiple regression analysis, only quadriceps force was a significant determinant of utilization of health care services. We conclude that utilization of health care services in patients with chronic obstructive pulmonary disease is related to ventilatory and peripheral muscle force. Whether or not reduced muscle force is simply an expression of disease severity remains to be determined.

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.

A Swedish version of the appraisal of Self-Care Agency (ASA) scale.

The "Appraisal of Self-care Agency" scale (the ASA scale) is designed to measure self-care agency in accordance with Orem's self-care deficit theory of nursing. The aim of this study was to obtain a reliable Swedish version of the ASA scale by measuring the internal consistency. ASA-A for self-appraisal and ASA-B for appraisal of another were tested with a convenience sample of 52 elderly in-patients and 53 caregivers in six geriatric care units. Cronbach's alpha reliability coefficient was 0.59 for the ASA-A scores, 0.77 for ASA-B scores obtained by caregivers comprising different professions, and 0.87 for scores obtained by registered nurses. Further testing of both validity and reliability is needed if this version of the scale is to be used in nursing research and practice.