11 research outputs found

    Dimethylarginines in critically ill patients with severe sepsis or septic shock

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    Objective:We investigated the trend of asymmetric dimethylarginine (ADMA) and symmetryc dimethyarginine (SDMA) in patients with severe sepsis and septic shock, and the relationship between dymethylarginines, organ failure, sepsis status and intensive care unit (ICU) mortality. Design: A prospective observational study carried out in three general adults Italian ICUs. Patient: Consecutive patients with severe sepsis or septic shock admitted to ICUs between December 2004 and March 2007. Methods: Plasma ADMA and SDMA were determined immediately after enrolment and on the third, sixth and twelfth days. Organ failure score, sepsis status, standard blood parameters and ICU outcome were collected. Resul\uc3\ub2ts: Twenty-nine consecutive patients were enrolled. ADMA and SDMA were higher in patients than in healthy volunteers. Sixteen patients who suffered from septic shock during ICU stay had a higher avarage value of daily ADMA and SDMA. ADMA was significantly related to arterial pH level, daily Sequential Organ Failure Assessment score and creatinine. Independent variables predicting ICU mortality were Simplified Acute Physiology Score II, mean Sequential Organ Failure Assessment score and SDMA. Conclusions: Dimethylarginines are not only markers of body catabolism may have a high metabolic activity, tightly related to the risk of adverse outcome of sepsis syndrome

    Does regulation increase the rate at which doctors leave practice? Analysis of routine hospital data in the English NHS following the introduction of medical revalidation

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    Background: In 2012, the UK introduced medical revalidation, whereby to retain their licence all doctors are required to show periodically that they are up to date and fit to practise medicine. Early reports suggested that some doctors found the process overly onerous and chose to leave practice. This study investigates the effect of medical revalidation on the rate at which consultants (senior hospital doctors) leave NHS practice, and assesses any differences between the performance of consultants who left or remained in practice before and after the introduction of revalidation. Methods: We used a retrospective cohort of administrative data from the Hospital Episode Statistics database on all consultants who were working in English NHS hospitals between April 2008 and March 2009 (n = 19,334), followed to March 2015. Proportional hazard models were used to identify the effect of medical revalidation on the time to exit from the NHS workforce, as implied by ceasing NHS clinical activity. The main exposure variable was consultants’ time-varying revalidation status, which differentiates between periods when consultants were (a) not subject to revalidation—before the policy was introduced, (b) awaiting a revalidation recommendation and (c) had received a positive recommendation to be revalidated. Difference-in-differences analysis was used to compare the performance of those who left practice with those who remained in practice before and after the introduction of revalidation, as proxied by case-mix-adjusted 30-day mortality rates. Results: After 2012, consultants who had not yet revalidated were at an increased hazard of ceasing NHS clinical practice (HR 2.33, 95% CI 2.12 to 2.57) compared with pre-policy levels. This higher risk remained after a positive recommendation (HR 1.85, 95% CI 1.65 to 2.06) but was statistically significantly reduced (p < 0.001). We found no statistically significant differences in mortality rates between those consultants who ceased practice and those who remained, after adjustment for multiple testing. Conclusion: Revalidation appears to have led to greater numbers of doctors ceasing clinical practice, over and above other contemporaneous influences. Those ceasing clinical practice do not appear to have provided lower quality care, as approximated by mortality rates, when compared with those remaining in practice

    The Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaLuAtion (UMBRELLA) : objectives, design, and baseline results

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    PURPOSE: In oncology, RCTs are often beset by slow recruitment, limited generalizability, and strong preferences for interventions by patients and physicians. The cohort multiple randomized controlled trial (cmRCT) is an innovative design with the potential to overcome those challenges. In cmRCT, a prospective cohort serves as an infrastructure for multiple RCTs. We implemented cmRCT in a clinical breast cancer setting by creating UMBRELLA-a large prospective cohort of breast cancer and DCIS patients/survivors. METHODS: For all participants, clinical data and patient-reported outcomes (PROs, i.e., quality of life, fatigue, anxiety and depression, physical activity, work ability, and cosmetic satisfaction) are being collected at regular time-intervals for a period of 10 years. These data are being used both for observational and randomized studies. For each intervention to be tested against standard care, a subcohort of eligible patients is identified within UMBRELLA. From this subcohort, a random sample of patients is offered the intervention. Their outcomes are compared to the outcomes of patients receiving standard care. RESULTS: So far, between October 2013 and July 2016, we have recruited 1308 participants. In this period, 1308/1486 (88%) patients who were invited for participation in UMBRELLA consented to cohort participation. Of these patients, 1138 (87%) gave broad consent for randomization to future interventions. Return rate for PROs at baseline were 80%, and varied from 67 to 74% during follow-up. Several observational studies-and the first randomized intervention study-are currently ongoing. CONCLUSIONS: Results from UMBRELLA show that this novel study design is feasible and acceptable to patients in a clinical breast cancer setting. We invite researchers who are interested in conducting randomized or observational studies within the UMBRELLA cohort to contact the UMBRELLA scientific advisory board

    Impact of modern-day axillary treatment on patient reported arm morbidity and physical functioning in breast cancer patients

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    Purpose: To reduce arm morbidity, routine axillary lymph node dissection (ALND) is often omitted or replaced by axillary radiotherapy (AxRT) in patients with limited nodal involvement. We evaluated patient-reported arm morbidity and physical functioning in breast cancer patients undergoing modern-day axillary treatment. Methods: All patients within the UMBRELLA cohort undergoing local radiotherapy with sentinel lymph node biopsy (SLNB), ALND and/or AxRT were selected. Patient-reported arm morbidity and physical functioning were assessed with EORTC QLQ C30/BR23 questionnaires up to eighteen months after initiation of radiotherapy. Patient-reported outcomes were compared between patients with SLNB only, ALND only, AxRT (level I–II), AxRT (level I–IV) or AxRT plus ALND by means of mixed model analysis. Results: In total, 949 patients were identified; 641 (68%) SLNB only, 57 (6%) ALND only, 94 (10%) AxRT level I–II, 72 (8%) AxRT level I–IV and 85 (9%) ALND + AxRT. SLNB only resulted in the least arm morbidity scores. ALND + AxRT resulted in most arm morbidity, with clinically relevant differences at 18 months. AxRT (level I–II or level I–IV) resulted in significantly less arm symptoms in the first 3 months compared to ALND. Arm symptom scores between those receiving AxRT on levels I–II and I–IV were similar. Conclusion: Of all axillary management strategies, ALND plus AxRT is associated with worst patient-reported outcomes. AxRT resulted in less arm morbidity compared to ALND. Selective radiotherapy treatment of the axilla, i.e. radiotherapy of levels I–II only instead of levels I–IV, did not lead to clinically relevant reduced arm morbidity
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