Efficacy of subcutaneous sumatriptan in the acute treatment of early-morning migraine: a placebo-controlled trial

Abstract. Objectives. To evaluate the efficacy of self-administered subcutaneous sumatriptan in the acute treatment of early-morning migraine attacks. Design. A double-blind, randomized, placebo-controlled, cross-over study. Setting. Thirteen neurology centres in France. Subjects. Patients of either sex, 18–65 years old, with two to six attacks of migraine (according to the International Headache Society (IHS) criteria, with or without aura) per month, of which at least two had to be early-morning migraine attacks. One-hundred-and-one patients were included, 96 being evaluable for the first attack and 81 for the cross-over design. Interventions. Two migraine attacks (grade 2/3) were treated with sumatriptan (6 mg) or placebo, with an optional second injection 1–24 h later. Main outcome measures. The primary end-point was headache relief: reduction in headache severity from grade 2/3 (moderate/severe) to grade 1/0 (mild/none) 2 h after treatment. Results. Sumatriptan was superior to placebo for headache relief (32 [78%] vs. 11 [28%] at the first attack; 29 [73%] vs. 8 [20%] at the second; P < 0.001). Because of a significant carry-over effect for some of the secondary end-points, a parallel-group analysis of the first attack was performed, which confirmed a significantly higher efficacy of sumatriptan for all end-points: pain-free rate (22 [46%] vs. 7 [15%]; P = 0.001) and use of a second injection (26 [53%] vs. 38 [81%]; P = 0.004). Sumatriptan was preferred by 74% of patients vs. 17% for placebo, and 9% expressed no preference (P < 0.0001). After complete relief, headache reappeared in 8/23 (35%) patients with sumatriptan and 3/7 (43%) with placebo. Adverse events were significantly more frequent with sumatriptan but they were minor and transient. Conclusion. Subcutaneous sumatriptan auto-injection is an effective and well-tolerated acute treatment of early-morning migraine attacks allowing earlier return to normal activity.     

一类“近乎双线性”系统及其稳定化反馈控制

本文定义了一类“近乎双线性”系统。可用以近似一类奇异摄动双线性系统,而且可以描述某些实际工业对象。并发现其控制器的设计较方便。文中还给出了一种简单的反馈控制器的设计方法。又对一类多输入双线性系统,提出一种设计反馈控制器的改进方案,根据Lyapunov定理得到一非线性反馈控制律。以上设计方法分别对某合成氨反应器作了应用研究,仿真结果表明了方法的有效性。     

The effect of design of residential homes in creating dependency among confused elderly residents: A study of elderly demented residents and their ability to find their way around homes for the elderly

A study of 13 homes for elderly people examining the effect of the environment on demented residents looked into the complexity of the design from the residents' point of view. Two principal tools were used in this investigation: ‘route diagrams’, which describe a resident's use of the home, and a measure devised to indicate each resident's ability to find her way around the home. These are described and the relationship between them explored. From this the following tentative conclusions are drawn:

• (i) The variables that influence a resident's ability to find her way around differ between group and communally designed homes.
• (ii) It would appear that group homes provide a more favourable design, especially in the case of physically frail demented elderly people.
• (iii) In group homes, the level of lighting is an important aid to a demented person in finding her way around.
• (iv) In communal homes, residents seem most able to find their way around homes that have been adapted from older premises.
• (v) In both types of home, ‘meaningful decision points’ can be seen as aids to a resident finding her way around.

     

Transdermal Dual-Controlled Delivery of Contraceptive Drugs: Formulation Development,in Vitro and in Vivo Evaluations,and Clinical Performance

Several transdermal contraceptive device (TCD) formulations were developed to provide a dual-controlled transdermal delivery of levonorgestrel (LN), a potent progestin, and 17-estradiol (E₂), a natural estrogen. Using a sensitive HPLC method, the in vitro release and skin permeation profiles of LN and E₂ from various TCD formulations were simultaneously characterized in the hydrodynamically well-calibrated Valia–Chien skin permeation cells and both were found to follow zero-order kinetics. The rates of drug release and skin permeation were observed to vary significantly depending upon some formulation parameters. Six-month stability studies were performed on seven formulations at room and elevated temperatures (37 and 45°C), and two (Formulations 4 and 5) were found to be acceptable, based on drug recovery, release rate, and skin permeation rate data. Judging from the 6-month accelerated stability studies, it is projected these two formulations will have shelf-life of at least 2 years. As a result of development of an efficient manufacturing process, Formulation 4 was selected for further evaluation. One-week primary skin irritation evaluation in 6 rabbits indicated that Formulation 4 is nonirritating, and it was thus selected for Phase I clinical bioavailability/dose proportionality studies in 12 healthy female volunteers of child-bearing age. Results of pharmacokinetic and pharmacodynamic analyses demonstrated that it is capable of achieving and maintaining a steady-state serum level of LN throughout the 3-week treatment period by weekly applications of one or two TCD patches (10 or 20 cm²). A dose proportionality was obtained in the serum drug levels, daily dose delivered, and contraception efficacy. An excellent correlation was obtained for the rates of transdermal delivery determined by the in vitro studies using human cadaver skin, the in vivo studies in rabbits, and the clinical studies in living subjects.     

ESCMID generic competencies in antimicrobial prescribing and stewardship: towards a European consensus

Objective

To develop a consensus-based set of generic competencies in antimicrobial prescribing and stewardship for European prescribers through a structured consensus procedure.

Enhancing a primary care environment: a case study of effects on patients and staff in a single general practice

BACKGROUND: Few studies have examined the effect on patients and staff of the physical environment in primary care facilities. AIM: To explore changes in patient and staff satisfaction, patient anxiety, and patient-doctor communication when a GP surgery moves from old premises to enhanced purpose-built accommodation. DESIGN OF STUDY: Questionnaire surveys, interviews, and focus groups pre- and post move. SETTING: An urban general practice in Bristol. METHOD: Patient questionnaires assessed anxiety (Spielberger State-Trait Anxiety Inventory; STAI), satisfaction with the environment, and communication during the consultation. Staff questionnaires assessed satisfaction with the environment and job satisfaction. Qualitative methods explored patient and staff views in more depth. RESULTS: A total of 1118 pre-move and 954 post-move patient questionnaires showed significant increases in satisfaction scores for reception/waiting areas (mean 6.46, 95% confidence interval [CI]=5.97 to 6.95) and consulting rooms (mean 3.80, 95% CI=3.44 to 4.15) in the new premises. Patients' satisfaction with patient-doctor communication also increased (mean 0.88, 95% CI=0.30 to 1.46) and anxiety scores were significantly reduced before and after the consultation in the new premises compared with the old (STAI mean difference before consultation 0.72, 95% CI=0.37 to 1.08; mean after consultation 0.37, 95% CI=0.03 to 0.72). Patients highlighted the increased space and light, more modern appearance, greater comfort, and novel works of art in the new surgery. Staff workplace satisfaction increased significantly after moving and remained higher than in the old building. CONCLUSION: This large-scale study examining the effects of a UK primary care environment on patients and staff shows that an enhanced environment is associated with improvements in patients' perception of patient-doctor communication, reduction in anxiety, and increases in patient and staff satisfaction.     

Computer science education for medical informaticians

The core curriculum in the education of medical informaticians remains a topic of concern and discussion. This paper reports on a survey of medical informaticians with Master's level credentials that asked about computer science (CS) topics or skills that they need in their employment. All subjects were graduates or "near-graduates" of a single medical informatics Master's program that they entered with widely varying educational backgrounds. The survey instrument was validated for face and content validity prior to use. All survey items were rated as having some degree of importance in the work of these professionals, with retrieval and analysis of data from databases, database design and web technologies deemed most important. Least important were networking skills and object-oriented design and concepts. These results are consistent with other work done in the field and suggest that strong emphasis on technical skills, particularly databases, data analysis, web technologies, computer programming and general computer science are part of the core curriculum for medical informatics.     

Assessing graduate programs for healthcare information management/technology (HIM/T) executives

This paper describes a methodology to assess health/medical informatics graduate-level education curricula. The authors used the Certified Professional in Healthcare Information Management Systems (CPHIMS) exam objectives published by the Healthcare Information and Management Systems Society (HIMSS) as the basis for their assessment. The authors compared the 69 CPHIMS exam objectives against four health/medical informatics program course objectives as stated in the selected program's online graduate catalog. Results showed that the two programs with management as a focus addressed the majority (67 and 59%) of the CPHIMS objectives within core and elective courses combined. Overall, the other two programs addressed closer to a third of the CPHIMS objectives (36 and 32%). This methodology could prove to be useful in assisting students interested in graduate-level training programs with a tool by which to measure the congruence of the curricula of different programs with the mission of the programs and with their own professional interests.     

Designs for Instruction, Designs for Change: Distributing Knowledge of Evidence-Based Practice

We comment on the target article by Weingardt (this issue), which discusses recent advances in instructional design and technology (IDT) and their implications for dissemination of evidence-based practices. These arguments are extended to the topic of psychological intervention design, and possibilities for new intervention structures are briefly explored. Finally, comments are offered on maintaining a careful balance between technological and social processes in the effort to promote the dissemination of innovative and evidence-based psychological procedures.     

Publication Guidelines for Heart Rate Studies in Man

Publication guidelines are provided for the collection, quantification, and analysis of heart rate data.