Der Schlagwortkatalog des Instituts für Sprachwissenschaft der Universität Köln

Das hier vorgestellte Schlagwortkatalogsystem ist die Zusammenfassung diverser Vorarbeiten, die, teilweise in Verbindung mit Seminaren, Übungen und dem Kölner Universalienprojekt, in den vergangenen Semestern am Institut für Sprachwissenschaft der Universität Köln durchgeführt wurden, um Methoden einer effizienten wissenschaftlichen Dokumentation zu erarbeiten und zu erproben. Vor etwa einem Jahr wurde mit dem Aufbau eines entsprechenden Schlagwortkatalogs begonnen, für dessen Benutzer dieses Papier erstellt worden ist. Wir glauben jedoch, auch demjenigen, der nicht mit unserem Kölner Katalog arbeitet, Anregungen zur Verarbeitung wissenschaftlicher Information geben zu können

Informative value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA)

Background "Patient-Reported Outcome" (PRO) is used as an umbrella term for different concepts for measuring subjectively perceived health status e. g. as treatment effects. Their common characteristic is, that the appraisal of the health status is reported by the patient himself. In order to describe the informative value of PRO in Health Technology Assessment (HTA) first an overview of concepts, classifications and methods of measurement is given. The overview is complemented by an empirical analysis of clinical trials and HTA-reports on rheumatoid arthritis and breast cancer in order to report on type, frequency and consequences of PRO used in these documents. Methods For both issues systematic reviews of the literature have been performed. The search for methodological literature covers the publication period from 1990 to 2009, the search for clinical trials of rheumatoid arthritis and breast cancer covers the period 2005 to 2009. Both searches were performed in the medical databases of the German Institute of Medical Documentation and Information (DIMDI). The search for HTA-reports and methodological papers of HTA-agencies was performed in the CRD-Databases (CRD = Centre for Reviews and Dissemination) and by handsearching the websites of INAHTA member agencies (INAHTA = International Network of Agencies for Health Technology Assessment). For all issues specific inclusion and exclusion criteria were defined. The methodological quality of randomized controlled trials (RCT) was assessed by a modified version of the Cochrane Risk of Bias Tool. For the methodological part information extraction from the literature is structured by the report's chapters, for the empirical part data extraction sheets were constructed. All information is summarized in a qualitative manner. Results Concerning the methodological issues the literature search retrieved 158 documents (87 documents related to definition or classification, 125 documents related to operationalisation of PRO). For the empirical analyses 225 RCT (rheumatoid arthritis: 77; breast cancer: 148) and 40 HTA-reports and method papers were found. The analysis of the methodological literature confirms the role of PRO as an umbrella term for a variety of different concepts. The newest classification system facilitates the description of PRO measures by construct, target population and the method of measurement. Steps of operationalisation involve defining a conceptual framework, instrument development, exploration of measurement properties or, possibly, the modification of existing instruments. Seven out of 59 RCT analysing the effects of antibody therapy for rheumatoid arthritis define PRO as the primary endpoint, 38 trials utilize composite measures (ACR, DAS) and ten trials report clinical or radiol ogic al parameters as the primary endpoint. Six out of 123 chemotherapy trials for breast cancer define PRO as the primary endpoint, while 98 trials report clinical endpoints (survival, tumour response, progression) in their primary analyses. Discrepancies in the number of trials result from inaccurate specifications of endpoints in the publications. This distribution is reflected in the HTA-reports: while almost all reports on rheumatoid arthritis refer to PRO, this is only the case in about half of the reports on breast cancer. Conclusions As definition and classification of PRO are concerned, coherent concepts are found in the literature. Their operationalisation and implementation must be guided by scientific principles. The type and frequency of PRO used in clinical trials largely depend on the disease analysed. The HTA-community seems to pursue the utilization of PRO proactively - in case of missing data the need for further research is stated.Hintergrund und Zielsetzung Patient-Reported Outcome (PRO) wird als Oberbegriff für unterschiedliche Konzepte zur Messung subjektiv empfundener Gesundheitszustände verwendet. Sie sind dadurch gekennzeichnet, dass der Patient selbst seine Einschätzung berichtet. Um den Stellenwert von PRO im Kontext von HTA-Verfahren (HTA = Health Technology Assessment) zu beschreiben, wird zunächst eine Übersicht über Konzepte, Klassifikationen und methodische Messansätze erstellt. Diese Übersicht wird ergänzt um eine empirische Analyse von klinischen Studien und HTA-Berichten mit dem Ziel, Art, Häufigkeit und Konsequenzen der verwendeten PRO zu dokumentieren. Methodik Beide Fragestellungen werden mithilfe von systematischen Literaturübersichten bearbeitet. Für den methodischen Teil wird in den medizinnahen Datenbanken des Deutschen Instituts für Medizinische Dokumentation und Information (DIMDI) mit einer Recherchestrategie aus drei Modulen im Zeitraum von 1990 bis 2009 gesucht. Die Recherche nach randomisierten klinischen Studien (RCT) zu den Krankheitsbildern rheumatoide Arthritis (RA) und Mammakarzinom erfolgt ebenfalls in den Datenbanken des DIMDI, für den Zeitraum von 2005 bis 2009. Die Recherche nach HTA-Berichten und -Methodenpapieren umfasst die Datenbanken des Centre for Reviews and Dissemination (CRD) und Handsuchen. Für alle Fragestellungen werden spezifische Ein- und Ausschlusskriterien zur Literaturselektion definiert. Die methodische Qualität der RCT wird mithilfe eines in Anlehnung an das "Risk of Bias Tool" der Cochrane Collaboration konzipierten Instruments bewertet. Die Informationsextraktion erfolgt für den methodischen Teil strukturiert durch die Kapitelgliederung, für den empirischen Teil in Extraktionsbögen. Alle Informationen werden qualitativ beschreibend zusammengefasst. Ergebnisse Aus den Recherchen können 158 Dokumente zur Bearbeitung der methodischen Fragestellungen (87 Dokumente zu Definition/Klassifikation; 125 Dokumente zur Operationalisierung) und 225 RCT (77 RA, 148 Mammakarzinom) sowie 40 HTA-Berichte zur Bearbeitung der empirischen Fragestellungen gewonnen werden. Die Analysen zu Definitionen bestätigen PRO als Oberbegriff für eine Vielzahl von patientenberichteten Endpunkten. Das neueste Klassifikationssystem ermöglicht die Beschreibung der PRO nach dem Konstrukt, der Zielpopulation und der Messmethode. Ausführungen zur Operationalisierung beziehen sich auf den Konzeptrahmen, die Instrumentenentwicklung, -eigenschaften und -modifikationsmöglichkeiten. Von 59 Studien zur Antikörpertherapie der RA verwenden sieben ausschließlich PRO, 38 gemischte Zielgrößen (American College of Rheumatology [ACR], Disease Activity Score [DAS]) und zehn rein klinische bzw. radiologische Parameter als primäre Outcomes. Von 123 Studien zur Chemotherapie des Mammakarzinoms stützen sich nur sechs auf PRO als primäre Zielgröße; 98 Studien gebrauchen klinische Parameter (Überlebenszeit, Tumoransprechen, Progression). Abweichungen von der Gesamtzahl resultieren aus ungenauen Angaben der Zielgrößen. Diese Verteilung spiegelt sich auch in den analysierten HTA-Berichten wieder. In den Berichten zur RA werden durchweg PRO-Zielgrößen berichtet, während in den Berichten zum Mammakarzinom dies in knapp der Hälfte der Publikationen der Fall ist. Zusammenhänge zwischen Studienqualität und der Verwendung von PRO sind nicht erkennbar. Schlussfolgerungen Für die Definition und die Klassifikation von PRO existieren inzwischen schlüssige Konzepte, deren Umsetzung wissenschaftlichen Kriterien genügen muss. Die Häufigkeit und die Art der in klinischen Studien verwendeten PRO variieren abhängig vom untersuchten Krankheitsbild. Im Kontext von HTA wird die Notwendigkeit zur Erfassung von PRO wahrgenommen, bei fehlenden Daten wird Forschungsbedarf formuliert

The Excess Costs of Depression and the Influence of Sociodemographic and Socioeconomic Factors: Results from the German Health Interview and Examination Survey for Adults (DEGS)

Introduction The aim of this study was to estimate excess costs of depression in Germany and to examine the influence of sociodemographic and socioeconomic determinants. Methods Annual excess costs of depression per patient were estimated for the year 2019 by comparing survey data of individuals with and without self-reported medically diagnosed depression, representative for the German population aged 18–79 years. Differences between individuals with depression (n = 223) and without depression (n = 4540) were adjusted using entropy balancing. Excess costs were estimated using generalized linear model regression with a gamma distribution and log-link function. We estimated direct (inpatient, outpatient, medication) and indirect (sick leave, early retirement) excess costs. Subgroup analyses by social determinants were conducted for sex, age, socioeconomic status, first-generation or second-generation migrants, partnership, and social support. Results Total annual excess costs of depression amounted to €5047 (95% confidence interval [CI] 3214–6880) per patient. Indirect excess costs amounted to €2835 (1566–4103) and were higher than direct excess costs (€2212 [1083–3341]). Outpatient (€498), inpatient (€1345), early retirement (€1686), and sick leave (€1149) excess costs were statistically significant, while medication (€370) excess costs were not. Regarding social determinants, total excess costs were highest in the younger age groups (€7955 for 18–29-year-olds, €9560 for 30–44-year-olds), whereas total excess costs were lowest for the oldest age group (€2168 for 65+) and first-generation or second-generation migrants (€1820). Conclusions Depression was associated with high excess costs that varied by social determinants. Considerable differences between the socioeconomic and sociodemographic subgroups need further clarification as they point to specific treatment barriers as well as varying treatment needs.Peer Reviewe

Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with somatoform disorders

Background: The EQ-5D is a generic questionnaire providing a preference-based index score applicable to cost-utility analysis. This is the first study to validate the EQ-5D in patients with somatoform disorders. Methods: Data of the EQ-5D descriptive system, the British and the German EQ-5D index and the EQ Visual Analogue Scale, the Patient Health Questionnaire 15, the Patient Health Questionnaire 9, the Whiteley Index 7 and the Short Form 36 were collected from 294 patients at baseline, 244 at 6 months and 256 at 12 months after baseline. The discriminative ability of the EQ-5D was evaluated by comparison with a general population sample and by the ability to distinguish between different symptom severities. Convergent validity was analysed by assessing associations between the EQ-5D and the other instruments. Responsiveness was evaluated by analysing the effects on scores between two measurements in groups of patients reporting worse, same or better health. The Bonferroni correction was employed. Results: For all items of the EQ-5D except ‘self-care’, patients with somatoform disorders reported more problems than the general population. The EQ-5D showed discriminative ability in patients with different symptom severities. For nearly all reference instruments there were significant differences in mean scores between respondents with and without problems in the various EQ-5D items and strong correlations with the EQ Visual Analogue Scale and the EQ-5D index scores. Evidence for the responsiveness of the EQ-5D could only be found for patients with better health; effects were medium at the utmost. Conclusions: The EQ-5D showed a considerable validity and a limited responsiveness in patients with somatoform disorders. Trial registration: Current Controlled Trials ISRCTN5528079

Genetic monitoring detects an overlooked cryptic species and reveals the diversity and distribution of three invasive Rattus congeners in South Africa

Background: South Africa's long and extensive trade activity has ensured ample opportunities for exotic species introduction. Whereas the rich biodiversity of endemic southern African fauna has been the focus of many studies, invasive vertebrates are generally overlooked despite potential impacts on biodiversity, health and agriculture. Genetic monitoring of commensal rodents in South Africa which uncovered the presence of Rattus tanezumi, a South-East Asian endemic not previously known to occur in Africa, provided the impetus for expanded studies on all invasive Rattus species present. Results: To this end, intensified sampling at 28 South African localities and at one site in Swaziland, identified 149 Rattus specimens. Cytochrome b gene sequencing revealed the presence of two R. tanezumi, seven R. rattus and five R. norvegicus haplotypes in south Africa. Phylogenetic results were consistent with a single, recent R. tanezumi introduction and indicated that R. norvegicus and R. rattus probably became established following at least two and three independent introductions, respectively. Intra- and inter-specific diversity was highest in informal human settlements, with all three species occurring at a single metropolitan township site. Rattus norvegicus and R. rattus each occurred sympatrically with R. tanezumi at one and five sites, respectively. Karyotyping of selected R. rattus and R. tanezumi individuals identified diploid numbers consistent with those reported previously for these cryptic species. Ordination of bioclimatic variables and MaxEnt ecological niche modelling confirmed that the bioclimatic niche occupied by R. tanezumi in south Africa was distinct from that occupied in its naturalised range in south-east Asia suggesting that factors other than climate may influence the distribution of this species. Conclusions: This study has highlighted the value of genetic typing for detecting cryptic invasive species, providing historical insights into introductions and for directing future sampling. The apparent ease with which a cryptic species can become established signals the need for broader implementation of genetic monitoring programmes. In addition to providing baseline data and potentially identifying high-risk introduction routes, the predictive power of ecological niche modelling is enhanced when species records are genetically verified

A mathematical epidemiological model of gram-negative Bartonella bacteria : does differential ectoparasite load fully explain the differences in infection prevalence of Rattus rattus and Rattus norvegicus?

We postulate that the large difference in infection prevalence, 24% versus 5%, in R. norvegicus and R. rattus, respectively, between these two co-occurring host species may be due to differences in ectoparasite and potential vector infestation rates.Acompartmental model, representative of an infectious system containing these two Rattus species and two ectoparasite vectors, was constructed and the coefficients of the forces of infection determined mathematically. The maximum difference obtained by the model in the prevalence of Bartonella in the two Rattus species amounts to 4.6%, compared to the observed mean difference of 19%. Results suggest the observed higher Bartonella infection prevalence in Rattus norvegicus compared to Rattus rattus, cannot be explained solely by higher ectoparasite load. The model also highlights the need for more detailed biological research on Bartonella infections in Rattus and the importance of the flea vector in the spread of this disease.The National Research Foundation (NRF)http://www.tandfonline.com/toc/tjbd20ab201

Guideline-based stepped and collaborative care for patients with depression in a cluster-randomised trial

Guidelines recommend stepped and collaborative care models (SCM) for depression. We aimed to evaluate the effectiveness of a complex guideline-based SCM for depressed patients. German primary care units were cluster-randomised into intervention (IG) or control group (CG) (3:1 ratio). Adult routine care patients with PHQ-9 ≥ 5 points could participate and received SCM in IG and treatment as usual (TAU) in CG. Primary outcome was change in PHQ-9 from baseline to 12 months (hypothesis: greater reduction in IG). A linear mixed model was calculated with group as fixed effect and practice as random effect, controlling for baseline PHQ-9 (intention-to-treat). 36 primary care units were randomised to IG and 13 to CG. 36 psychotherapists, 6 psychiatrists and 7 clinics participated in SCM. 737 patients were included (IG: n = 569 vs. CG: n = 168); data were available for 60% (IG) and 64% (CG) after 12 months. IG showed 2.4 points greater reduction [95% confidence interval (CI): -3.4 to -1.5, p < 0.001; Cohen's d = 0.45] (adjusted PHQ-9 mean change). Odds of response [odds ratio: 2.8; 95% CI: 1.6 to 4.7] and remission [odds ratio: 3.2; 95% CI: 1.58 to 6.26] were higher in IG. Guideline-based SCM can improve depression care

Symptom trajectories in patients with panic disorder in a primary care intervention: Results from a randomized controlled trial (PARADISE)

This analysis aims to identify and characterize symptom trajectories in primary care patients with panic disorder with/without agoraphobia (PD/AG) who participated in a primary care team based training involving elements of cognitive behavioural therapy (CBT). Growth Mixture Modeling was used to identify different latent classes of change in patients with PD/AG (N = 176) who underwent treatment including CBT elements. We identified three patient classes with distinct similar trajectories. Class 1 (n = 58, mean age: 46.2 years +/- 13.4 years, 81% women) consisted of patients with an initially high symptom burden, but symptoms declined constantly over the intervention period. Symptoms of patients in class 2 (n = 89, mean age: 44.2 years +/- 14.5 years, 67.4% women) declined rapidly at the beginning, then patients went into a plateau-phase. The third class (n = 29, mean age: 47.0 years +/- 12.4 years, 65.5% women) was characterized by an unstable course and had the worse outcome. Our findings show that only a minority did not respond to the treatment. To identify this minority and refer to a specialist would help patients to get intensive care in time

Evidence of a contact zone between two Rhabdomys dilectus (Rodentia : Muridae) mitotypes in Gauteng province, South Africa

Recent studies have described the presence of several mitochondrial lineages within Rhabdomys, which was previously considered to be a monotypic genus. The exact distributional limits of the species and subspecies and their contact zones are unclear. In this study we demonstrate that two monophyletic Rhabdomys dilectus mitochondrial lineages are present at two northern Gauteng province sampling sites in South Africa. Cytochrome b gene sequences, 896 nucleotides in length, generated for 36 Rhabdomys samples identified 10 unique haplotypes corresponding to eight R. dilectus dilectus haplotypes (from 32 individuals) and two R. d. chakae haplotypes (from four individuals). The present study provides the first empirical evidence for a contact zone for two R. dilectus conspecific mitochondrial lineages and contributes to the refinement of Rhabdomys distributional maps in southern Africa.South African National Research Foundationhttp://www.tandfonline.com/loi/tafz202016-03-31hb201

Bartonellae of the Namaqua rock mouse, Micaelamys namaquensis (Rodentia : Muridae) from South Africa

The aim of this study was to determine Bartonella prevalence and diversity in Namaqua rock mice, Micaelamys namaquensis, a species endemic to South Africa, which can attain pest status. A total of 100 heart samples collected monthly from March to December were screened for Bartonella genome presence using three primer sets targeting the citrate synthase (gltA) gene, the NADH dehydrogenase gamma subunit (nuoG) gene and the RNA polymerase b-subunit-encoding gene (rpoB). An overall prevalence of 44% was obtained, with no statistically significant differences or correlations between infection rates and rodent sex, month of capture or season of capture. Phylogenetic analysis of 34 unambiguous gltA sequences revealed the presence of three discrete Bartonella lineages in M. namaquensis, one of which corresponds to Bartonella elizabethae, a species with known zoonotic potential.The study was funded by grants awarded to ADSB and NCB by the South African National Research Foundation (NRF)http://www.elsevier.com/locate/vetmicab201