A randomized controlled trial protocol assessing the effectiveness, safety and cost-effectiveness of methotrexate vs. ciclosporin in the treatment of severe atopic eczema in children: the TREatment of severe Atopic eczema Trial (TREAT).

BACKGROUND: Oral systemic immunomodulatory medication is regularly used off-licence in children with severe atopic eczema. However, there is no firm evidence regarding the effectiveness, safety, cost-effectiveness and impact on quality of life from an adequately powered randomized controlled trial (RCT) using systemic medication in children. OBJECTIVES: To assess whether there is a difference in the speed of onset, effectiveness, side-effect profile and reduction in flares post-treatment between ciclosporin (CyA) and methotrexate (MTX), and also the cost-effectiveness of the drugs. Treatment impact on quality of life will also be examined in addition to whether FLG genotype influences treatment response. In addition, the trial studies the immune-metabolic effects of CyA and MTX. METHODS: Multicentre, parallel group, assessor-blind, pragmatic RCT of 36 weeks' duration with a 24-week follow-up period. In total, 102 children aged 2-16 years with moderate-to-severe atopic eczema, unresponsive to topical treatment will be randomized (1 : 1) to receive MTX (0·4 mg kg-1 per week) or CyA (4 mg kg-1 per day). RESULTS: The trial has two primary outcomes: change from baseline to 12 weeks in Objective Severity Scoring of Atopic Dermatitis (o-SCORAD) and time to first significant flare following treatment cessation. CONCLUSIONS: This trial addresses important therapeutic questions, highlighted in systematic reviews and treatment guidelines for atopic eczema. The trial design is pragmatic to reflect current clinical practice.

Optimisation of vasculitis disease assessments in clinical trials, clinical care and long-term databases.

The systemic vasculitides are a group of rare, chronic, relapsing, but often progressive inflammatory conditions. They are associated with a significant burden of morbidity both due to scarring from the disease itself and as a consequence of treatment with glucocorticoids and other potent immunosuppressive agents. Careful assessment of disease activity is critical to guide appropriate use of these potentially toxic therapies. It is also important to differentiate features of active disease from those attributable to damage, which will not respond to immunosuppression. As these are chronic complex conditions, the impact on a patient's functional ability and quality of life are also important considerations. Given the lack of a reliable biomarker for assessment of disease activity or damage in systemic vasculitis, clinical tools developed and validated for use initially in clinically trials are key outcome measures in the evaluation of these patients. While the conduct of randomised clinical trials in vasculitis has been significantly enhanced by the development and use of validated outcome measures, regular use of validated disease activity and damage measurements as part of routine care offers a structured approach, which can serve as the basis of justifying treatment decisions. The authors review the concepts of clinical assessment tools used in the evaluation of patients with systemic vasculitis in the setting of clinical practice, clinical trials and long term databases with particular emphasis on disease activity, damage, prognosis and function.

Weekend operating room on call staffing requirements.

This article describes a statistical method used to determine the minimum number of OR teams that should be on call for urgent procedures, in-house versus on standby from home, to minimize labor costs. The OR manager obtains the number of ORs staffed at each hour of the 24-hour period of interest (e.g., 7 AM Saturday to 7 AM Sunday) from the surgical suite's information system. The minimum number of total staffed hours needed to care for patients is calculated for a prespecified level of the acceptable risk of inadequate staffing. A method used to determine whether each staff member should work in-house or on standby from home then is introduced. This method enumerates all possible combinations of shifts to find the one with the lowest cost, and it ensures a prespecified service level. An example based on 248 weeks of data collected from a large surgical suite is presented, and staffing for emergency procedures is reviewed.

Scheduling surgical cases into overflow block time- computer simulation of the effects of scheduling strategies on operating room labor costs.

UNLABELLED: "Overflow" block time is operating room (OR) time for a surgical group's cases that cannot be completed in the regular block time allocated to each surgeon in the surgical group. Having such overflow block time increases OR utilization. The optimal way to schedule patients into a surgical group's overflow block time is unknown. In this study, we developed a scheduling strategy that balances the OR manager's need to reduce staffing costs and the needs of patients and surgeons for flexibility in choosing the dates and times of cases. We used computer simulation to evaluate our scheduling strategy. Surgeons and patients (i) can schedule the case into any overflow block within 2 wk; (ii) can only schedule the case into a "first case of the day" start time more than 2 wk in the future if there is not enough open time for the case within 2 wk; (iii) must schedule the case to be done within 4 wk; and (iv) are encouraged to perform the case on the earliest possible date. Staffing costs were lowest when the OR manager did not incorporate surgeon and patient preferences when scheduling cases into overflow block time. The strategy we developed provides surgeons and patients with some flexibility in scheduling, while only increasing OR staffing costs slightly over the minimum achieved when the OR manager controls scheduling. IMPLICATIONS: The strategy we developed provides surgeons and patients with some flexibility in scheduling, while increasing OR staffing costs only slightly over the minimum achieved when the OR manager controls scheduling. Staffing costs were lowest when the operating room (OR) manager did not incorporate surgeon and patient preferences when scheduling cases into overflow block time.

A strategy for deciding operating room assignments for second-shift anesthetists.

UNLABELLED: We developed a relief strategy for assigning second-shift anesthetists to late-running operating rooms. The strategy relies on a statistical method which analyzes historical case durations available from surgical services information systems to estimate the expected (mean) remaining hours in cases after they have begun. We tested our relief strategy by comparing the number of hours that first-shift anesthetists would work overtime if second-shift anesthetists were assigned using our strategy versus if the anesthesia coordinator knew in advance the exact amount of time remaining in each case. Our relief strategy resulted in 3.4% to 4.9% more overtime hours for first-shift anesthetists than the theoretical minimum, as would have been obtained had perfect retrospective knowledge been available. Few additional staff hours would have been saved by supplementing our relief strategy with other methods to monitor case durations (e.g., real-time patient tracking systems or closed circuit cameras in operating rooms). IMPLICATIONS: A relief strategy that relies only on analyzing historical case durations from an operating room information system to predict the time remaining in cases performs well at minimizing anesthetist staffing costs.

The implications of head injury for family relationships.

Many of those sustaining head injury recover to the point that they no longer require hospital care. However, the family frequently has to cope with an individual with varying degrees of disability involving physical, psychological, cognitive and social dysfunctioning. This review of the literature briefly considers the possible effects that head injury may have for the injured person before going on to discuss the consequences that such an injury may have for the family of that individual. The family's need for information and education is highlighted and it is suggested that the nurse has an important role to play in this context.

Uncensored open access gastroscopy--limited resources--unlimited demand.

In the first 3 yr of an uncensored open access gastroscopy service in a County Hospital, 891 patients attended for first gastroscopy. The data on these patients is presented and compared with a randomly selected group who attended for gastroscopy in the yr prior to the establishment of the service having come to the normal Consultant clinics. In the open access group the gastroscopy examination was normal in 29 per cent (32 per cent comparator group), 31 per cent had major abnormalities (33 per cent comparator group) and 40 per cent had minor abnormalities (35 per cent comparator group). Delay time from referral to endoscopy was 37 days for open access patients (45 days comparator group). Only 6 per cent of open access patients were brought back to O.P.D. (47 per cent comparator group) and 72 per cent of open access patients returned directly to their family doctor (28 per cent comparator group). A comparison of the Clonmel findings with British centres reporting their results shows a broadly similar picture. It is concluded that almost 1,300 unnecessary clinic visits were avoided by the provision of the open access service, some reduction in delay time to gastroscopy was achieved, the family doctor maintained control of patient management in the great majority of patients, the pattern of referral was not inappropriate and compared very well with the comparator group. Over the 3 yr there was a large increase in the number of gastroscopies performed which caused resource difficulties. It is recommended that adequate planning of these requirements should be carried out before an open access service is started. At least 1 additional dedicated gastroscopy only endoscopy service per week would be required.

Management and economic perspectives on efficiency.

Efficiency has different connotations and denotations in management, organizational behavior, and economics. This article explores different economic and organizational orientations that have given rise to alternative definitions with the hope that better understanding of these perspectives will improve terminology and theory building.

Ethics, jurisprudence, and economics in the medical school curriculum.

Medical ethics, medical jurisprudence, and medical economics are recognized as important components of a medical school curriculum. These subjects were introduced through a course given at the University of California, Davis, School of Medicine. Four aspects of the format and content of the course were instrumental to its success. Teaching principles of medical ethics within the context of jurisprudence and economics permitted the students to gain an understanding of the institutions and processes that act as positive and negative constraints on physicians' clinical and professional behavior. The course was offered during the fourth year following required clinical rotations so that all aspects of the course could be based on the clinical experiences of the students. It was presented in a continuing medical education format away from the normal teaching environment of first- and second-year classrooms and third-year clerkships. Finally, the course was designed by a multidisciplinary, multidepartmental planning group that included students.