Standardized audiotape versus recorded consultation to enhance informed consent to a clinical trial in breast oncology

BACKGROUND: The purpose of this study was to systematically compare two audiotape formats for the delivery of information relevant to informed consent to participate in a clinical trial in breast oncology, and to establish the feasibility of adding a consultation recording protocol to a clinical treatment trial. METHOD: Participants were 69 women with newly diagnosed breast cancer and 21 oncologists from 5 Canadian cancer centers. Patients were block randomized to one of three groups: 1. standardized audiotape; 2. consultation audiotape; or 3. both audiotapes. Patients received their tapes immediately following the clinical trial consultation. Patient outcomes included perception of being informed about clinical trials, knowledge of information relevant to providing informed consent to a clinical trial, and satisfaction with communication during the consultation. RESULTS: The consultation audiotapes contained less trial-related information than the standardized audiotape but there were no differences in clinical trial knowledge or perception of being informed across the intervention groups. Patients expressed a marginally significant preference for consultation audiotapes over standardized audiotapes. CONCLUSIONS: Patients tended to prefer receiving an audiotape of their own consultation over a standardized audiotape. The majority of oncologists considered the audiotape intervention feasible but were less enthusiastic about being involved in a larger study given the accrual challenges that arose when trying to "piggy-back" one randomized controlled trial on an existing clinical trial.     

Interferon-γ in healthy subjects: selective modulation of inflammatory mediators

BACKGROUND: It is suggested that interferon-gamma (IFN-gamma), like other cytokines, is a mediator in the host inflammatory response, which could be of importance in the pathophysiology of sepsis. The role of IFN-gamma in human host inflammatory responses, however, has not been studied. DESIGN: In a placebo-controlled trial we studied the acute effects of IFN-gamma administration on host inflammatory mediators in healthy men: i.e. the cytokine/chemokine cascade system, acute-phase proteins, activation markers of the innate cellular immunity and coagulation/fibrinolysis parameters. RESULTS: IFN-gamma increased plasma levels of interleukin-6 (IL-6), IL-8 and IFN-gamma-inducible protein-10 (IP-10) (P < 0.05), but did not affect plasma levels of other cytokines (IL-4, IL-10, tumour necrosis factor-alpha, IL-12p40/p70). Plasma concentrations of C-reactive protein and secretory phospholipase A2 both increased (P < 0.05). Plasma levels of the leucocyte activation marker elastase-alpha1-antitrypsin complexes increased after IFN-gamma administration (P < 0.05), IFN-gamma increased the percentage of high-affinity Fcgamma-receptor (FcgammaRI) -positive neutrophils (P < 0.05), but did not affect the mean fluorescence intensity of FcgammaRI on neutrophils. Procoagulant and profibrinolytic effects of IFN-gamma were evidenced by increased plasma levels of prothrombin fragment F1 + F2, tissue-plasminogen activator and plasmin-alpha2-antiplasmin complexes (P < 0.05). CONCLUSION: We conclude that IFN-gamma selectively affects host inflammatory mediators in humans.     

The influence of bright light during the daytime upon circadian rhythm of core temperature and its implications for nocturnal sleep

Abstract The purpose of the present study was to investigate how bright light during the daytime could influence circadian rhythms of core temperature and nocturnal sleep. Seven females (age 20 ± 2 years) served as participants. The participants lived in the experimental unit for 4 days and were exposed to either 6000 lx (bright) or 200 lx (dim) light during the daytime. Rectal temperature (T_re) was measured during the experimental period. Subjective alertness was measured by the Kansei-gakuin Sleeping Scale five times a day. The minimum T_re was significantly lower after bright exposure ( P < 0.05). The T_re fell rapidly after bright exposure before they retired ( P < 0.05) and increased more rapidly during bright light after they woke up ( P < 0.05). The morning wakefulness under bright exposure was more active than under dim exposure ( P < 0.05). The melatonin secretion at wake up during bright exposure was significantly lower than during dim exposure ( P < 0.05). Exposure to bright light during daytime lowered the nocturnal level of T_re, its evening fall was faster and the morning rise quicker. This suggests that indoor light during daytime should be bright enough to promote healthy sleep at night.     

Reduction of Circulating Secretory Phospholipase A2 Levels by Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody in Patients with Severe Crohn's Disease

Background: Secretory phopholipase A₂ group II (sPLA₂-II) has pro-inflammatory effects. The impor\tance of tumor necrosis factor (TNF) for induction of plasma sPLA₂-II in humans was studied in two groups of subjects. Subjects: Six healthy volunteers received a single intravenous injection of recombinant human TNF or isotonic saline at random. Ten patients with active Crohn's disease received a single intravenous infusion of an anti-TNF chimeric monoclonal antibody, cA₂. Results: TNF infusion in healthy volunteers resulted in an increase of sPLA2     

Mittheilungen aus der chirurgischen Klinik zu Freiburg in Baden

Ohne Zusammenfassung     

Relative contribution of contact and complement activation to inflammatory reactions in arthritic joints.

Although both the complement and contact system are thought to contribute to the inflammatory reaction in arthritic joints, only activation of complement has so far been well established, whereas contact activation and its contribution to arthritis has not been systematically explored. Complement and contact activation were assessed in 71 patients with inflammatory arthropathies and 11 with osteoarthritis using sensitive assays for C3a, and C1-inhibitor (C1INH)-kallikrein and C1INH-factor XIIa complexes respectively. Increased plasma concentrations of kallikrein-and factor XIIa-C1INH complexes were found in two and seven of the 71 patients with inflammatory arthropathies, respectively, and in none of the patients with osteoarthritis. Increased synovial fluid concentrations of kallikrein and factor XIIa complexes occurred in 13 and 15 patients with inflammatory joint diseases respectively, and in two patients with osteoarthritis. Contact system parameters did not correlate with clinical symptoms, local activity, or neutrophil activation. In contrast, synovial fluid concentrations of C3a and C1INH-C1 complexes were increased in all patients and in 20 patients with inflammatory arthropathies respectively, and were higher in patients with a higher local activity score. Synovial fluid C3a correlated with parameters of neutrophil activation such as lactoferrin. Increased plasma concentrations of C3a and C1INH-C1 complexes occurred in 13 and 11 patients with inflammatory joint diseases, and in one and two patients with osteoarthritis respectively. Plasma concentrations of C3a correlated with the number of painful joints. Thus contact activation occurs only sporadically in patients with arthritis and contributes little if anything to the local inflammatory reaction and neutrophil activation. These latter events are significantly related to the extent of complement activation.     

Accurate measurement of intraarterial pressure through radial artery catheters in neonates

A technique is described for accurate measurement of intraarterial pressure through radial artery catheters in neonates. The technique, which can be used for short-term monitoring, uses cannulation of the radial artery with a 24-gauge Teflon catheter, connected by a Luer-Lok fitting to a threeway stopcock and a high-fidelity tip transducer. In vitro studies showed that the system is linear and the frequency response is flat (±3 dB) up to 50 Hz. The technique permits gathering of high-quality pressure data and can be used in the area of neonatal clinical research for short-term monitoring. It needs to be developed further before routine application in clinical practice can be recommended.     

Corticosteroid therapy-induced obesity in children

The severity and persistence of corticosteroid-induced obesity were evaluated retrospectively in 23 children aged 1-14 yrs requiring more than 60 days of therapy with prednisone for idiopathic nephrotic syndrome. Mean relative weight (after clearing of proteinuria) at initiation of therapy was 107 +/- 10 percent. Peak relative weight on therapy was 119 +/- 15 percent following a mean total of 31 months of cumulative steroid therapy. The most recent available relative weight in remission at least 6 months following cessation of therapy was 107 +/- 18 percent. The number of children whose relative weight exceeded 120 percent at initiation of, during and following therapy was 3, 10, and 4, respectively. In those with normal initial relative weight (less than 110%) there was no persistent obesity. Two of three initially obese patients (relative weight greater than 120%) remained obese. All patients with persistent obesity following therapy had initial relative weight of at least 110 percent and peak relative weight of more than 130 percent. The risk of persistent obesity as a result of chronic corticosteroid therapy in initially normal weight children who do not exceed 130 percent relative weight during therapy appears to be small.