3,683,837 research outputs found

    Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND) : a randomised, controlled, open-label, phase 3b/4 trial

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    Background Clostridium difficile infection causes severe complications and frequently recurs. An extended-pulsed fidaxomicin regimen might facilitate sustained clinical cure by prolonging C difficile suppression and supporting gut microbiota recovery. We aimed to compare clinical outcomes of extended-pulsed fidaxomicin with standard vancomycin. Methods In this randomised, controlled, open-label, superiority study, we recruited hospitalised adults aged 60 years and older with confirmed C difficile infection at 86 European hospitals. Patients were randomly assigned (1: 1) using an interactive web response system to receive extended-pulsed fidaxomicin (200 mg oral tablets, twice daily on days 1-5, then once daily on alternate days on days 7-25) or vancomycin (125 mg oral capsules, four times daily on days 1-10), stratified by baseline C difficile infection severity, cancer presence, age (>= 75 years vs Findings Between Nov 6, 2014, and May 5, 2016, 364 patients were enrolled and randomly assigned to receive extended-pulsed fidaxomicin or vancomycin. 362 patients received at least one dose of study medication (181 in each group). 124 (70%) of 177 patients in the modified full analysis set receiving extended-pulsed fidaxomicin achieved sustained clinical cure 30 days after end of treatment, compared with 106 (59%) of 179 patients receiving vancomycin (difference 11% [95% CI 1.0-20.7], p=0.030; odds ratio 1.62 [95% CI 1.04-2.54]). Incidence of treatment-emergent adverse events did not differ between extended-pulsed fidaxomicin (121 [67%] of 181) and vancomycin (128 [71%] of 181) treatment arms. One death in the vancomycin arm was considered by the investigator to be related to study drug. Interpretation Extended-pulsed fidaxomicin was superior to standard-dose vancomycin for sustained cure of C difficile infection, and, to our knowledge, extended-pulsed fidaxomicin recurrence rates in this study are the lowest observed in a randomised clinical trial of antibiotic treatment for C difficile infection.Peer reviewe

    Clinical audit project in undergraduate medical education curriculum: an assessment validation study

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    Clinical leadership in service redesign using Clinical Commissioning Groups: a mixed-methods study

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    Background: A core component of the Health and Social Care Act 2012 (Great Britain. Health and Social Care Act 2012. London: HMSO; 2012) was the idea of devolving to general practitioners (GPs) a health service leadership role for service redesign. For this purpose, new Clinical Commissioning Groups (CCGs) were formed in the English NHS.Objectives: This research examined the extent to which, and the methods by which, clinicians stepped forward to take up a leadership role in service redesign using CCGs as a platform.Design: The project proceeded in five phases: (1) a scoping study across 15 CCGs, (2) the design and administration of a national survey of all members of CCG governing bodies in 2014, (3) six main in-depth case studies, (4) a second national survey of governing body members in 2016, which allowed longitudinal comparisons, and (5) international comparisons.Participants: In addition to GPs serving in clinical lead roles for CCGs, the research included insights from accountable officers and other managers and perspectives from secondary care and other provider organisations (local authority councillors and staff, patients and the public, and other relevant bodies).Results: Instances of the exercise of clinical leadership utilising the mechanism of the CCGs were strikingly varied. Some CCG teams had made little of the opportunity. However, we found other examples of clinicians stepping forward to bring about meaningful improvements in services. The most notable cases involved the design of integrated care for frail elderly patients and others with long-term conditions. The leadership of these service redesigns required cross-boundary working with primary care, secondary care, community care and social work. The processes enabling such breakthroughs required interlocking processes of leadership across three arenas: (1) strategy-level work at CCG board level, (2) mid-range operational planning and negotiation at programme board level and (3) the arena of practical implementation leadership at the point of delivery. The arena of the CCG board provided the legitimacy for strategic change; the programme boards worked through the competing logics of markets, hierarchy and networks; and the practice arena allowed the exercise of clinical leadership in practical problemsolving, detailed learning and routinisation of new ways of working at a common-sense everyday level.Limitations: Although the research was conducted over a 3-year period, it could be argued that a much longer period is required for CCGs to mature and realise their potential.Conclusions: Despite the variation in practice, we found significant examples of clinical leaders forging new modes of service design and delivery. A great deal of the service redesign effort was directed at compensating for the fragmented nature of the NHS – part of which had been created by the 2012 reforms. This is the first study to reveal details of such work in a systematic way

    Credit and information in universal banking : a clinical study

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    We studied information and interaction processes in six lending relationships between a universal bank and medium sized firms. The study is based on the credit files of the respective firms. If no problems occur in these lending relationships, bank monitoring is based mainly on cheap, retrospective and internal data. In case of distress, more expensive, prospective and external information is used. The level of monitoring and the willingness to renegotiate the lending relationship depends on what the lending officers can learn about the future prospects of the firm from the behaviour of the debtors. We identify both signalling and bonding activities. Such learning from past behaviour seems to allow monitoring at low cost, whereas the direct observation of the firm's investment outlook seems to be very costly. Also, too much knowledge about the firm's investments might leave the bank in a very strong bargaining position and distort investment incentives. Therefore, the traditional view of credit assessment as observation of the quality of a borrower's investment programme needs to be reconsidered

    Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

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    Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials

    REGULATORY APPROVAL OF NEW MEDICAL DEVICES: A CROSS SECTIONAL STUDY

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    Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature. Data sources PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. Eligibility criteria for study selection Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.” Main outcome measures Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device. Results 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be “substantially equivalent” to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published. Conclusions We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study
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