Effectiveness of a standardized patient education program on therapy-related side effects and unplanned therapy interruptions in oral cancer therapy: a cluster-randomized controlled trial.

PURPOSE: Oral agents for cancer treatment are increasingly prescribed due to their benefits. However, oral cancer medications are difficult to handle and have a considerable potential for side effects. This type of therapy requires a high level of self-management competence by the patient. A standardized patient education program provided by physicians and oncology nurses may positively influence the handling of oral agents. The aim of the study was to evaluate the impact of a standardized patient education program provided by specially trained oncology nurses on therapy management regarding side effects and unplanned therapy interruptions. METHODS: One hundred sixty-five patients from 28 office-based oncology practices from all over Germany participated in this cluster-randomized controlled study. Patients of both intervention (n = 111) and standard care groups (n = 54) received the usual oncologist counseling; in addition, the patients from the intervention group (k = 17 practices) received an education from specially trained oncology nurses. The time of observation was 3 months per patient. RESULTS: The patients of the intervention group reported fewer side effects (skin rash, pain, fatigue, nausea, vomiting). Patients in the standard care group interrupted the therapy more frequently without informing their oncologist, compared to the intervention group. CONCLUSIONS: Patients benefit from a standardized patient education program provided by specially trained oncology nurses. They tend to handle side effects and critical situations better.

Tintelnotia, a new genus in Phaeosphaeriaceae harbouring agents of cornea and nail infections in humans.

Phaeosphaeriaceae is a family in the order Pleosporales containing numerous plant pathogens, endophytes, lichenised fungi, and environmental saprobes. A novel genus, Tintelnotia is introduced containing two species, one of which caused an eye infection and several nail infections in humans. All species of Tintelnotia produce conidia in soft pycnidia with a wide ostiole. The generic type species is T. opuntiae causing necrotic spots on cactus plants. The isolates of the human opportunist T. destructans showed variable susceptibility pattern to a panel of common antifungal agents. The MICs of amphotericin B, voriconazole, posaconazole and itraconazole were 1 µg/mL, complemented by an in vitro MEC of 16 µg/mL against caspofungin; the MIC of terbinafine was 0.125 µg/mL. The latter compound contributed to the successful therapy in the ocular mycosis refractory to standard antifungal therapy, the benefit of terbinafine should be highlighted as a therapeutic option especially in difficult-to-treat fungal keratitis.

[Memorandum IV: Theoretical and Normative Grounding of Health Services Research]. / Memorandum IV: Theoretische und normative Fundierung der Versorgungsforschung.

With Memoranda and other initiatives, the German Network for Health Service Research [Deutsches Netzwerk Versorgungsforschung e.V. (DNVF)] is fostering the methodological quality of care research studies for years. Compared to the standards of empirical research, questions concerning the role and function of theories, theoretical approaches and scientific principles have not been taken up on its own. Therefore, the DNVF e.V. has set up a working group in 2013, which was commissioned to prepare a memorandum on "theories in health care research". This now presented memorandum will primarily challenge scholars in health care services research to pay more attention to questions concerning the theoretical arsenal and the background assumptions in the research process. The foundation in the philosophy of science, the reference to normative principles and the theory-bases of the research process are addressed. Moreover, the memorandum will call on to advance the theorizing in health services research and to strengthen not empirical approaches, research on basic principles or studies with regard to normative sciences and to incorporate these relevant disciplines in health services research. Research structures and funding of health services research needs more open space for theoretical reflection and for self-observation of their own, multidisciplinary research processes.

[Turnover of Non-medical Staff in Outpatient Oncology Practices: Is Building Social Capital a Solution?]. / Fluktuation bei nicht-ärztlichem Personal in onkologischen Schwerpunktpraxen: Sozialkapitalaufbau als Lösungsansatz?

STUDY AIM: While a lot is known about potential and actual turnover of non-medical hospital staff, only few data exist for the outpatient setting. In addition, little is known about actual instruments which leaders can use to influence staff turnover in physician practices. In the literature, the social capital of an organisation, which means the amount of trust, common values and reciprocal behaviour in the organisation, has been discussed as a possible field of action. In the present study, staff turnover as perceived by outpatient haematologists and oncologists is presented and analysed as to whether social capital is associated with that staff turnover. In conclusion, measures to increase the social capital of a practice are presented. METHODS: The present study is based on data gathered in a questionnaire-based survey with members of the Professional Organisation of -Office-Based Haematologists and Oncologists (N=551). The social capital of the practice was captured from the haematologists and oncologists using an existing and validated scale. To analyse the impact of the practice's social capital on staff turnover, as perceived by the physicians, bivariate correlations and linear regression analyses were calculated. RESULTS: In total, 152 haematologists and oncologists participated in the study which represents a response rate of 28%. In the regression analyses, social capital appears as a significant and strong predictor of staff turnover (beta=-0.34; p<0.001). CONCLUSIONS: Building social capital within the practice may be an important contribution to reducing staff turnover although the underlying study design does not allow for drawing causal conclusions regarding this relationship. To create social capital in their practice, outpatient physicians may apply measures that facilitate social interaction among staff, foster trust and facilitate cooperation. Such measures may already be applied when hiring and training new staff, but also continuously when leading employees and when organising work tasks, e.g., by establishing regular team meetings.

[Keratomycosis - Therapy Standards and New Developments]. / Keratomykose - Therapiestandards und aktuelle Entwicklungen.

Mycotic keratitis is a comparatively rare but serious ophthalmological disease, that can possibly lead to a severe loss of vision up to blindness. Over the last two decades an increase of cases with mycotic keratitis has been noticed, which is possibly caused by an increased use of soft contact lenses. This article gives an overview of the typical clinical signs and symptoms of keratomycosis, tried and tested diagnostics and therapy as well as new diagnostic and therapeutic developments and findings.

Can a stressed oncologist be good in a consultation? A qualitative study on the oncologists' perception.

The aim of this exploratory study was to examine how the working conditions and job stress of private practice oncologists (PPOs) affect their interaction with patients. Data for the study were collected through semi-structured interviews with PPOs selected based on purposeful sampling criteria. The data were evaluated using content analysis. Factors perceived by PPOs to influence their level of stress and patient care were some of their own personal characteristics as well as working conditions both within and outside their practices. Apart from being able to name specific stressors (e.g., dysfunctional organisational workflow and interruptions during medical encounters), the oncologists also mentioned individual and organisational resources (e.g., professional experience, well-educated nurses and good work organisation) for coping with job stress and improving interaction with patients. Within this study, we identified some obstacles on the individual and organisational level for good patient care, as working conditions which might lead to time pressure and stress, which subsequently have an impact on quality in patient care (e.g., less time for personal issues during patient consultations). Future stress research should conduct a more in-depth investigation of these and other interventions at both the individual and organisational levels in order to improve patient care.

[Communication preferences of oncology patients]. / Kommunikationspräferenzen onkologischer Patienten.

PURPOSE: After testing the psychometric properties of a new questionnaire that measures patient preferences for patient-physician communication (KOPRA questionnaire), the communication preferences of cancer patients were described. In order to do this, the preferences were differentiated according to sociodemographic subgroups and a comparison was made to the preferences of patients with chronic back pain and chronic ischaemic heart disease. METHODS: N=1,635 patients from 31 medical oncology practices were surveyed. For the KOPRA questionnaire, reliability, unidimensionality, and fit to the Rasch model were tested. Hierarchical models were used to conduct subgroup analyses and comparisons with other diseases. RESULTS: The psychometric properties of the KOPRA are satisfactory to good. For patients, the 4 communication domains (patient participation and patient orientation, effective and open communication, emotionally supportive communication, communication about personal circumstances) measured by the KOPRA questionnaire are equally important. Women generally have higher expectations of the physician's communicative behaviour. Affective communication is considerably more important for cancer patients than for back pain or cardiac patients. CONCLUSION: The KOPRA questionnaire is well suited for examining the communication preferences of cancer patients. In general, physician behaviour associated with high scores in all 4 KOPRA dimensions is optimal. Especially in cases where the 4 communication aspects conflict with each other, the physician's communication style should be individualised.

Formation of trinuclear rhodium-hydride complexes [{Rh(PP*)H}3-(µ2-H)3(µ3-H)][anion]2--during asymmetric hydrogenation?

Recently described and fully characterized trinuclear rhodium-hydride complexes [{Rh(PP*)H}3(µ2-H)3(µ3-H)][anion]2 have been investigated with respect to their formation and role under the conditions of asymmetric hydrogenation. Catalyst-substrate complexes with mac (methyl (Z)-N-acetylaminocinnamate) ([Rh(tBu-BisP*)(mac)]BF4, [Rh(Tangphos)(mac)]BF4, [Rh(Me-BPE)(mac)]BF4, [Rh(DCPE)(mac)]BF4, [Rh(DCPB)(mac)]BF4), as well as rhodium-hydride species, both mono-([Rh(Tangphos)-H2(MeOH)2]BF4, [Rh(Me-BPE)H2(MeOH)2]BF4), and dinuclear ([{Rh(DCPE)H}2(µ2-H)3]BF4, [{Rh(DCPB)H}2(µ2-H)3]BF4), are described. A plausible reaction sequence for the formation of the trinuclear rhodium-hydride complexes is discussed. Evidence is provided that the presence of multinuclear rhodium-hydride complexes should be taken into account when discussing the mechanism of rhodium-promoted asymmetric hydrogenation.

Benefit of polyhexamethylene biguanide in Fusarium keratitis.

PURPOSE: To report a series of 3 patients with soft contact lens-related Fusarium keratitis. Two of them were treated with the antiamoebic polyhexamethylene biguanide 0.02% (PHMB) in combination with antifungal drugs, and 1 patient was treated with PHMB as sole antifungal regimen. METHODS: Chart review of 3 patients treated with PHMB in Fusarium keratitis. Two of them were refractory to the commonly used therapy. The antifungal power of PHMB and propamidine isethionate was tested against the patients' isolates as well as against the clinical isolates from another 9 patients with ocular mould infections. RESULTS: An excellent outcome could be achieved in 2 patients with Fusarium solani keratitis refractory to common antifungal treatment by the additional use of PHMB 0.02%. In another patient PHMB alone was sufficient to resolve Fusarium proliferatum infection. The drug was well tolerated. In all patients repeated abrasion was done for better penetration of the drugs. PHMB revealed a marked in vitro antifungal activity for the three Fusarium isolates as well as for another 9 isolates of ocular infections from other patients including also the genera Scedosporium, Aspergillus and Rhizopus giving minimal inhibitory concentrations ranging from 1.56 to 3.12 µg/ml. CONCLUSIONS: Fusarium keratitis is a severe ocular infection. We report on the use of PHMB in 3 patients given additionally or as sole antifungal drug. We emphasize the benefit of PHMB 0.02% in Fusarium keratitis which might be considered as a therapeutic option especially in cases refractory to common antifungal therapy and possibly in keratitis due to other fungi.

[Giant cell arteritis (temporal arteritis, Horton's arteritis): clinical characteristics and management]. / Morbus Horton (Arteriitis temporalis, Riesenzellarteriitis): Klinik, Diagnostik, Histologie, Therapie.

Giant cell arteritis can cause diagnostic difficulties due to its heterogeneous symptomatology. Characteristic ophthalmic and systemic symptoms of Horton's disease are discussed. The clinical course is described on the basis of typical patients, which shows that generic symptoms do not have to coexist. The Horton's arteritis potentially represents a systemic vasculitis that requires early diagnosis and treatment in order to avoid dramatic ophthalmic consequences, in worst cases blindness. The erythrocyte sedimentation rate (ESR) represents the most important laboratory parameter. Although temporal artery biopsy remains the only confirmatory procedure for a definite diagnosis, imaging procedures such as sonography, magnetic resonance imaging, ultrasound biomicroscopy are useful in supporting the clinical diagnosis. Highly dosed corticosteroid therapy should always be indicated when suspicious clinical symptoms are present, even without any dramatic laboratory parameter changes. Initial high dosages are indicated up to 1 gram daily depending on the severity of the disease. Subsequently a slow ESR titrated reduction of the dose is necessary under control of inflammation values, symptomatology and side effects. Occasionally a lifelong immunsuppressive therapy is indispensable. The long-term treatment should take place in close cooperation with the general practitioner, rheumatologist, neurologist and if necessary further specialists.

Computer-based training for the treatment of partial blindness.

Partial blindness after brain injury has been considered non-treatable. To evaluate whether patients with visual-field defects can profit from computer-based visual restitution training (VRT), two independent clinical trials were conducted using patients with optic nerve (n = 19) or post-chiasmatic brain injury (n = 19). In post-chiasma patients, VRT led to a significant improvement (29.4%) over baseline in the ability to detect visual stimuli; in optic nerve patients, the effects were even more pronounced (73.6% improvement). Visual-field enlargements were confirmed by the observation of a visual-field expansion of 4.9 degrees-5.8 degrees of visual angle and improved acuity in optic nerve patients. Ninety five percent of the VRT-treated patients showed improvements, 72.2% confirmed visual improvements subjectively. Patients receiving a placebo training did not show comparable improvements. In conclusion, VRT with a computer program improves vision in patients with visual-field defects and offers a new, cost-effective therapy for partial blindness.

[Retinotopic mapping of the human visual cortex with functional magnetic resonance imaging - basic principles, current developments and ophthalmological perspectives]. / Retinotope Kartierung des menschlichen visuellen Kortex mit funktioneller Magnetresonanztomografie - Grundlagen, aktuelle Entwicklungen und Perspektiven für die Ophthalmologie.

Since its initial introduction in the mid-1990 s, retinotopic mapping of the human visual cortex, based on functional magnetic resonance imaging (fMRI), has contributed greatly to our understanding of the human visual system. Multiple cortical visual field representations have been demonstrated and thus numerous visual areas identified. The organisation of specific areas has been detailed and the impact of pathophysiologies of the visual system on the cortical organisation uncovered. These results are based on investigations at a magnetic field strength of 3 Tesla or less. In a field-strength comparison between 3 and 7 Tesla, it was demonstrated that retinotopic mapping benefits from a magnetic field strength of 7 Tesla. Specifically, the visual areas can be mapped with high spatial resolution for a detailed analysis of the visual field maps. Applications of fMRI-based retinotopic mapping in ophthalmological research hold promise to further our understanding of plasticity in the human visual cortex. This is highlighted by pioneering studies in patients with macular dysfunction or misrouted optic nerves.

Adjuvant chemoradiotherapy of advanced resectable rectal cancer: results of a randomised trial comparing modulation of 5-fluorouracil with folinic acid or with interferon-α.

BACKGROUND: Standard adjuvant chemoradiotherapy of rectal cancer still consists of 5-fluorouracil (5-FU) only. Its cytotoxicity is enhanced by folinic acid (FA) and interferon-α (INFα). In this trial, the effects of FA and IFNα on adjuvant 5-FU chemoradiotherapy in locally advanced rectal cancer were investigated. METHODS: Patients with R(0)-resected rectal cancer (UICC stage II and III) were stratified and randomised to a 12-month adjuvant chemoradiotherapy with 5-FU, 5-FU+FA, or 5-FU+IFNα. All patients received levamisol and local irradiation with 50.4 Gy. RESULTS: Median follow-up was 4.9 years (n=796). Toxicities (WHO III+IV) were observed in 32, 28, and 58% of patients receiving 5-FU, 5-FU+FA, and 5-FU+IFNα, respectively. No differences between the groups were observed for local or distant recurrence. Five-year overall survival (OS) rates were 60.3% (95% confidence interval (CI): 54.3-65.8), 60.4% (54.4-65.8), and 59.9% (53.0-66.1) for 5-FU, 5-FU+FA, and 5-FU+IFNα, respectively. A subgroup analysis in stage II (pT3/4pN0) disease (n=271) revealed that the addition of FA tended to reduce the 5-year local recurrence (LR) rate by 55% and increase recurrence-free survival and OS rates by 12 and 13%, respectively, relative to 5-FU alone. CONCLUSIONS: Interferon-α cannot be recommended for adjuvant chemoradiotherapy of rectal cancer. In UICC stage II disease, the addition of FA tended to lower LR and increased survival. The addition of FA to 5-FU may be an effective option for adjuvant chemoradiotherapy of UICC stage II rectal cancer.

Atomic layer deposition (ALD) as a coating tool for reinforcing fibers.

Layers of alumina were deposited on to bundled carbon fibers in an atomic layer deposition (ALD) process via sequential exposure to vapors of aluminium chloride and water, respectively. Scanning electron microscopic (SEM) images of the coated fibers revealed that each individual fiber within a bundle was coated evenly and separately, fibers are not bridged by the coating. SEM and transmission electron microscopic (TEM) images indicate that the coating was uniform and conformal with good adhesion to the fiber surface. Average deposition rate, measured from SEM images, was 0.06 nm per cycle at 500 °C. SEM also revealed that at deposition temperatures of 500 °C few of the fibers were damaged. At temperatures of 300 °C, no damaged fibers were observed, the average deposition rate decreased down to 0.033 nm per cycle. Oxidation resistance of the alumina-coated fibers was characterized by thermogravimetric analysis (TGA). The alumina coating improved oxidation resistance of the carbon fiber significantly. Oxidation onset temperature was 600 °C for fibers coated with a 45 nm thick alumina. Uncoated fibers, on the other hand, started to oxidize at temperatures as low as 250 °C.

[Memorandum registry for health services research]. / Memorandum Register für die Versorgungsforschung.

On August 30, 2010, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e. V. (DNVF e. V.)] approved the Memorandum III "Methods for Health Services Research", supported by their member societies mentioned as authors and published in this Journal [Gesundheitswesen 2010; 72: 739-748]. Registries in Health Services Research vary in their aims and research questions as well as in their designs, methods of data collection, and statistical analyses. This paper aims to provide both a methodological guideline for developers to ensure a high quality of a planned registry and, to provide an instrument for users of data from registries to assess their overall quality. First, the paper provides a definition of registries and presents an overview of objectives in Health Services Research where registries can be useful. Second, several areas of methodological importance for the development of registries are presented. This includes the different phases of a registry (i. e., conceptual and preliminary design, implementation), technical organisation of a registry, statistical analysis, reporting of results, data protection, and ethical/legal aspects. From these areas, several criteria are deduced to allow the assessment of the quality of a registry. Finally, a checklist to assess a registry's quality is presented.

[Herpes simplex keratitis. A short overview of the current therapy]. / Herpes-simplex-Keratitis. Ein kurzer Uberblick zur aktuellen Therapie.

In this review the current recommendations for the treatment of Herpes simplex keratitis are given - based on the literature, especially from 2000 till 2009. The medical treatment of epithelial, deep stromal keratitis, the prevention of recurrences and metaherpetic keratitis are discussed. Finally, a therapy scheme is presented.

[Test-retest reliability of a web-based colour vision test]. / Untersuchungen zur Re-Test Reliabilität eines webbasierten Farbsehtests.

BACKGROUND: Screening tests should be simple, with high acceptance, low costs and offer a high sensitivity and specificity as well as high reliability. The test-retest reliability of a web-based colour vision test was evaluated. METHOD: The results of 386 subjects, who had performed the web-based colour vision test with 25 colour plates twice (available at http://www.farbsehtest.de), were analysed from an mySQL data base. Retests were performed spontaneously, normally on the same day, or through an email newsletter with a request to repeat the test. Test-retest reliability was assessed by calculating the kappa coefficient and the corresponding confidence interval. The McNemar test was used as a complementary procedure to detect the presence of systematic differences between test results. RESULTS: The kappa coefficient rises with increasing time interval between the first test performance and the test repetition. Thus it was 0.24 when the test was repeated within one hour (confidence interval 0.07 - 0.41, n = 63), it increases to 0.83 (confidence interval 0.75 - 0.92, n = 240) in the subjects who repeated the test at the earliest after two years. While the proportion of failed tests (< 3 mistakes) in the second test performance markedly decreases when the test is repeated in the short term within one hour (p < 0.001, McNemar), we were unable to identify any systematic differences (p = 0.602) for a time interval of more than one day. CONCLUSIONS: The web-based colour vision test is a reliable screening test with good reproducible results as well under uncontrolled examination conditions. Subjects must perform the test with serious intent and should not aim at a positive test result by training or manipulation because of self-delusion. Test results are reliable if the time interval between test and retest is more than one day.

Aqueous humor concentrations of topically administered caspofungin in rabbits.

BACKGROUND: The echinocandin caspofungin (CAS) is a novel antifungal drug with fungicidal in vitro activity against all Candida spp., which are the most frequent cause of fungal keratitis. Penetration of CAS through the cornea into the aqueous humor after topical administration was investigated. METHODS: A CAS solution with a concentration of 7 mg/ml was applied onto each rabbit's cornea. Drug application after corneal epithelium abrasion was processed in different time intervals: single application with aqueous humor sampling after 1 and 2 h. In addition, after continuous application of CAS every 30 min, aqueous humor concentrations of CAS after 1, 2 and 5 h were analyzed by liquid-chromatography tandem mass spectrometry. RESULTS: Topical administration of CAS without corneal epithelium abrasion resulted in no detectable amounts of the drug in the aqueous humor. However, with corneal abrasion, after a single application, levels of 2.16 +/- 1.57 microg/ml (n = 6) were reached after 1 h and then decreased to 1.76 +/- 0.88 microg/ml (n = 2) after 2 h. After serial application every 30 min, the following intracameral levels of CAS were detected: after 1 h, 2.11 +/- 1.09 microg/ml (n = 6); after 2 h, 4.94 +/- 1.80 microg/ml (n = 5), and after 5 h, 3.45 +/- 2.11 microg/ml (n = 6). CONCLUSION: In the aqueous humor, therapeutic drug levels can be reached that cover the MICs of most fungi after epithelial abrasion. To achieve a sustained high level of CAS as an effective antifungal therapy for corneal keratitis, CAS should be administered topically every 30 min after removal of the corneal epithelium.

[Contact allergy to topical ophthalmological drugs - epidemiological risk assessment]. / Kontaktallergien gegen ophthalmologische Lokaltherapeutika - eine epidemiologische Risikobewertung.

BACKGROUND: Contact allergies (CA) against active agents of topical ophthalmological therapeutics, causing inflammation of the conjunctiva and/or the lid, are usually not life-threatening, but occur not infrequently. As yet, the assessment of the CA-eliciting risk has been based on clinical data alone, while a valid epidemiological risk assessment is lacking. MATERIALS AND METHODS: The Information Network of Departments of Dermatology supplied information on diagnostic results obtained in 4,102 patients patch-tested for suspected CA to ophthalmic drugs between 1995 and 2004. Clinical prevalences were extrapolated to incidences at the German population level. These estimates served as numerator for a relative incidence (RI), which included the nationwide frequency of prescriptions collected by the WIdO, Bonn, in terms of a standardised defined daily dose (DDD) as denominator. RESULTS: The estimated annual incidence of CA ranges from 155 (atropine sulphate) to 2077 (gentamicin sulphate) and can thus be regarded as moderate. If incidence estimates are related to prescription frequencies, the highest risk was found for kanamycin and neomycin sulphate (RI > 8 / 100,000 DDD). In contrast, the RI of pilocarpine-HCl (0.3) was virtually negligible. CONCLUSIONS: The substance-specific risk of CA has been evaluated for the first time and found to differ between therapeutics (with a similar spectrum of application). CA risk should be considered in differential therapeutic decision-making.