Rationale and design of the RIACT–study: a multi-center placebo controlled double blind study to test the efficacy of RItuximab in Acute Cellular tubulointerstitial rejection with B-cell infiltrates in renal Transplant patients: study protocol for a randomized controlled trial

BACKGROUND: Acute kidney allograft rejection is a major cause for declining graft function and has a negative impact on the long-term graft survival. The majority (90%) of acute rejections are T-cell mediated and, therefore, the anti-rejection therapy targets T-cell-mediated mechanisms of the rejection process. However, there is increasing evidence that intragraft B-cells are also important in the T-cell-mediated rejections. First, a significant proportion of patients with acute T-cell-mediated rejection have B-cells present in the infiltrates. Second, the outcome of these patients is inferior, which has been related to an inferior response to the conventional anti-rejection therapy. Third, treatment of these patients with an anti-CD20 antibody (rituximab) improves the allograft outcome as reported in single case observations and in one small study. Despite the promise of these observations, solid evidence is required before incorporating this treatment option into a general treatment recommendation. METHODS/DESIGN: The RIACT study is designed as a randomized, double-blind, placebo-controlled, parallel group multicenter Phase III study. The study examines whether rituximab, in addition to the standard treatment with steroid-boli, leads to an improved one-year kidney allograft function, compared to the standard treatment alone in patients with acute T-cell mediated tubulointerstitial rejection and significant B-cell infiltrates in their biopsies. A total of 180 patients will be recruited. DISCUSSION: It is important to clarify the relevance of anti-B cell targeting in T-cell mediated rejection and answer the question whether this novel concept should be incorporated in the conventional anti-rejection therapy. TRIAL REGISTRATION: Clinical trials gov. number: NCT0111766

Lessons from a one-year hospital-based surveillance of acute respiratory infections in Berlin- comparing case definitions to monitor influenza

<p>Abstract</p> <p>Background</p> <p>Surveillance of severe acute respiratory infections (SARI) in sentinel hospitals is recommended to estimate the burden of severe influenza-cases. Therefore, we monitored patients admitted with respiratory infections (RI) in 9 Berlin hospitals from 7.12.2009 to 12.12.2010 according to different case definitions (CD) and determined the proportion of cases with influenza A(H1N1)pdm09 (pH1N1). We compared the sensitivity and specificity of CD for capturing pandemic pH1N1 cases.</p> <p>Methods</p> <p>We established an RI-surveillance restricted to adults aged ≤ 65 years within the framework of a pH1N1 vaccine effectiveness study, which required active identification of RI-cases. The hospital information-system was screened daily for newly admitted RI-patients. Nasopharyngeal swabs from consenting patients were tested by PCR for influenza-virus subtypes. Four clinical CD were compared in terms of capturing pH1N1-positives among hospitalized RI-patients by applying sensitivity and specificity analyses. The broadest case definition (CD1) was used for inclusion of RI-cases; the narrowest case definition (CD4) was identical to the SARI case definition recommended by ECDC/WHO.</p> <p>Results</p> <p>Over the study period, we identified 1,025 RI-cases, of which 283 (28%) met the ECDC/WHO SARI case definition. The percentage of SARI-cases among internal medicine admissions decreased from 3.2% (calendar-week 50-2009) to 0.2% (week 25-2010). Of 354 patients tested by PCR, 20 (6%) were pH1N1-positive. Two case definitions narrower than CD1 but -in contrast to SARI- not requiring shortness of breath yielded the largest areas under the Receiver-Operator-Curve. Heterogeneity of proportions of patients admitted with RI between hospitals was significant.</p> <p>Conclusions</p> <p>Comprehensive surveillance of RI cases was feasible in a network of community hospitals. In most settings, several hospitals should be included to ensure representativeness. Although misclassification resulting from failure to obtain symptoms in the hospital information-system cannot be ruled out, a high proportion of hospitalized PCR-positive pH1N1-patients (45%) did not fulfil the SARI case-definition that included shortness of breath or difficulty breathing. Thus, to assess influenza-related disease burden in hospitals, broader, alternative case definitions should be considered.</p

Vakna patienters oro under operation : En litteraturstudie

Bakgrund: I samband med en operation kan patienter uppleva oro pre-, intra- och postoperativt. Regional anestesi möjliggör att patienten kan vara vaken under operationen men gör samtidigt att patienten och personalen kan behöva hantera den oro som kan uppstå. Det saknas kunskap kring hur patienter upplever oro under operationen.   Syfte: Syftet var att sammanställa patienters upplevelser av oro under kirurgiskt ingrepp i vaket tillstånd.    Metod: Studien genomfördes som en systematisk litteraturstudie. Artiklar söktes i databaserna PubMed och CINAHL. Insamlade data syntesterades genom meta-aggregation.   Resultat: Resultatet bestod av fem synteser med 13 underliggande kategorier. Följande synteser utarbetades: Kunskap och oro, En oroande miljö, En ansatt kropp, Kommunikation, Att hantera och lindra oro.    Slutsats: Det finns skillnader i vad som orsakar och lindrar oro hos patienter. För att lindra oro behöver operationsteamet anpassa omvårdnaden inför varje patient. Det finns en kunskapslucka när det kommer till patienters beskrivningar av operation.  

Vakna patienters oro under operation : En litteraturstudie

Bakgrund: I samband med en operation kan patienter uppleva oro pre-, intra- och postoperativt. Regional anestesi möjliggör att patienten kan vara vaken under operationen men gör samtidigt att patienten och personalen kan behöva hantera den oro som kan uppstå. Det saknas kunskap kring hur patienter upplever oro under operationen.   Syfte: Syftet var att sammanställa patienters upplevelser av oro under kirurgiskt ingrepp i vaket tillstånd.    Metod: Studien genomfördes som en systematisk litteraturstudie. Artiklar söktes i databaserna PubMed och CINAHL. Insamlade data syntesterades genom meta-aggregation.   Resultat: Resultatet bestod av fem synteser med 13 underliggande kategorier. Följande synteser utarbetades: Kunskap och oro, En oroande miljö, En ansatt kropp, Kommunikation, Att hantera och lindra oro.    Slutsats: Det finns skillnader i vad som orsakar och lindrar oro hos patienter. För att lindra oro behöver operationsteamet anpassa omvårdnaden inför varje patient. Det finns en kunskapslucka när det kommer till patienters beskrivningar av operation.  

Recognition of depression and anxiety and their association with quality of life, hospitalization and mortality in primary care patients with heart failure - study protocol of a longitudinal observation study

Background: International disease management guidelines recommend the regular assessment of depression and anxiety in heart failure patients. Currently there is little data on the effect of screening for depression and anxiety on the quality of life and the prognosis of heart failure (HF). We will investigate the association between the recognition of current depression/anxiety by the general practitioner (GP) and the quality of life and the patients' prognosis. Methods/Design: In this multicenter, prospective, observational study 3,950 patients with HF are recruited by general practices in Germany. The patients fill out questionnaires at baseline and 12-month follow-up. At baseline the GPs are interviewed regarding the somatic and psychological comorbidities of their patients. During the follow-up assessment, data on hospitalization and mortality are provided by the general practice. Based on baseline data, the patients are allocated into three observation groups: HF patients with depression and/or anxiety recognized by their GP (P+/+), those with depression and/or anxiety not recognized (P+/-) and patients without depression and/or anxiety (P-/-). We will perform multivariate regression models to investigate the influence of the recognition of depression and/or anxiety on quality of life at 12 month follow-up, as well as its influences on the prognosis (hospital admission, mortality). Discussion: We will display the frequency of GP-acknowledged depression and anxiety and the frequency of installed therapeutic strategies. We will also describe the frequency of depression and anxiety missed by the GP and the resulting treatment gap. Effects of correctly acknowledged and missed depression/anxiety on outcome, also in comparison to the outcome of subjects without depression/anxiety will be addressed. In case results suggest a treatment gap of depression/anxiety in patients with HF, the results of this study will provide methodological advice for the efficient planning of further interventional research

Improving competencies in evidence-based dementia care: Results from a pilot study on a novel inter-professional training course (the KOMPIDEM project)

Objective: In order to address well-known challenges in dementia care, an inter-professional course was developed to improve medical students’ and nursing students’ competencies in the provision of evidence-based care for people with dementia. The course comprises lectures, problem-based learning (PbL) tutorials and visitations to care facilities. A pilot study was conducted to evaluate the acceptance and feasibility of the inter-professional course.Methodology: Alongside preliminary implementation of the newly developed course, a pre-post survey was carried out involving all participating students. The questionnaire contained standardized and open-ended questions on participants’ views regarding the quality and relevance of several course components and characteristics. The data were analyzed by means of descriptive statistics.Results: When the course was offered the first time, multiple barriers became evident, leading to premature course termination and subsequent revision of the curriculum. When the revised course was offered, 10 medical students and 8 nursing students participated. The course proved feasible, and the median overall quality was rated as “2” (IQR 2–3) at a rating scale ranging from 1 (very good) to 6 (inadequate). Following aspects were most frequently judged positively: the course’s inter-professional scope, the visitations to care facilities and the PbL tutorials. Potential for improvement was particularly noted with regard to a more distinct focus on well-defined, mainly practical learning outcomes. There were no indications of systematic between-group differences in the medical and nursing students’ perceptions of the course program.Conclusions: The results confirmed the feasibility of the inter-professional course on dementia care and the relevance of its inter-professional scope. However, to ensure sustainable course implementation in the long term, further program adaptations based on current findings and further evaluation studies focusing on objective parameters of the process and outcome quality are required