The BrainIT group: concept and core dataset definition

Summary ¶Introduction. An open collaborative international network has been established which aims to improve inter-centre standards for collection of high-resolution, neurointensive care data on patients with traumatic brain injury. The group is also working towards the creation of an open access, detailed and validated database that will be useful for post-hoc hypothesis testing. In Part A, the underlying concept, the group coordination structure, membership guidelines and database access and publication criteria are described. Secondly, in part B, we describe a set of meetings funded by the EEC that allowed us to define a Core Dataset and we present the results of a feasibility exercise for collection of this core dataset. Methods. Four group meetings funded by the EEC have enabled definition of a Core Dataset to be collected from all centres regardless of specific project aim. A paper based pilot collection of data was conducted to determine the feasibility for collection of the core dataset. Specially designed forms to collect the core dataset demographic and clinical information as well as sample the time-series data elements were distributed by both email and standard mail to 22 BrainIT centres. A deadline of two months was set to receive completed forms back from centres. A pilot data collection of minute by minute physiological monitoring data was also performed. Findings. A core-dataset was defined and can be downloaded from the BrainIT web-site (go to Core dataset link at: www.brainit.org). Eighteen centres (82%) returned completed forms by the set deadline. Overall the feasibility for collection of the core data elements was high with only 10 of the 64 questions (16%) showing missing data. Of those 10 fields with missing data, the average number of centres not responding was 12% and the median 6%. An SQL database to hold the data has been designed and is being tested. Software tools for collection of the core dataset have been developed. Ethics approval has been granted for collection of multi-centre data as part of a pilot data collection study. Interpretation. The BrainIT network provides a more standardised and higher resolution data collection mechanism for research groups, organisations and the device industry to conduct multi-centre trials of new health care technology in patients with traumatic brain injury.Published online July 23, 2003     

在急性心衰中是否应使用主动脉内球囊反搏？

主动脉内球囊反搏在临床上应用于急性心肌梗死引起的心源性休克,但其有效性都是根据临床资料的回溯。《新英格兰医学杂志》新近报道了首个主动脉内球囊反搏的前瞻性多中心随机对照临床试验结果。本文介绍并分析了该试验,提出根据临床研究的最新结果不断评估并更新指南的重要性。     

Post-acute rehabilitation care for older people in community hospitals and general hospitals – Philosophies of care and patients' and caregivers' reported experiences: A qualitative study

Purpose.?This article contrasts community hospital and general hospital philosophies of care and examines how they relate to patients' and caregivers' experiences.

Methods.?Semi-structured interviews with 42 staff were used to produce care setting vignettes in six community hospitals and four general hospitals in the midlands and north of England. The vignettes were used with 26 patients and 10 caregivers in semi-structured interviews.

Results.?Community hospital and general hospital staff identified shared understandings of requirements for post-acute rehabilitation care for older people. Distinctive features were: general hospital – medical efficiency, helping patients get better, high standard of care, need for stimulation; community hospital – homelike setting, quiet, calm ambience, good views, orientated to elderly people, encouragement of social interaction, involvement of relatives in care. In the main there was symmetry between staff aspirations and patients' experience. However some concepts used and assumptions made by staff were not recognised by patients. These were characteristically reframed in patients' answers as if they were discussing subjective dimensions of care.

Conclusions.?There was patient and caregiver preference for the homelike environment of community hospitals. In care of older people, where the focus is rehabilitation, patient preferences are particularly pertinent and should be considered alongside clinical outcomes and cost-effectiveness.     

Evaluation of a single session with cooling garment for persons with multiple sclerosis – a randomized trial

Purpose. This research investigates the objective and subjective effects of wearing the Rehband® cooling garment.

Method. A multi-centre, randomized crossover study was conducted regarding 43 heat-sensitive persons with multiple sclerosis (MS), comparing active treatment with placebo. Subjects were tested immediately before and after intervention. Ten- (10TW) and 30-metre timed walk (30TW), oral temperature, spasticity, standing balance and timed up and go (TUG) and nine-hole peg test (NHPT) performance were measured. A study-specific questionnaire was used to evaluate subjective experiences.

Results. Active treatment produced statistically significant objective improvement in 10TW, 30TW, one-legged stance, tandem stance (right) and TUG; statistically significant subjective improvement was also found in fatigue, spasticity, weakness, balance, gait, transfers, ability to think clearly and time to recover. The coherence between the objective and subjective results indicates clinical relevance from the subjects' perspective. There were no statistically significant differences between treatments in terms of oral temperature, spasticity (measured by the modified Ashworth scale), tandem stance (left), step test or NHPT, or subjective signs such as difficulty in dressing, dysarthria or pain.

Conclusions. Active cooling with a Rehband® vest is likely to have a positive effect on everyday life in heat-sensitive persons with MS.     

Evaluation of the preliminary auditory profile test battery in an international multi-centre study

Abstract

Objective: This paper describes the composition and international multi-centre evaluation of a battery of tests termed the preliminary auditory profile. It includes measures of loudness perception, listening effort, speech perception, spectral and temporal resolution, spatial hearing, self-reported disability and handicap, and cognition. Clinical applicability and comparability across different centres are investigated. Design: Headphone tests were conducted in five centres divided over four countries. Effects of test-retest, ear, and centre were investigated. Results for normally-hearing (NH) and hearing-impaired (HI) listeners are presented. Study sample: Thirty NH listeners aged 19–39 years, and 72 HI listeners aged 22–91 years with a broad range of hearing losses were included. Results: Test-retest reliability was generally good and there were very few right/left ear effects. Results of all tests were comparable across centres for NH listeners after baseline correction to account for necessary differences between test materials. For HI listeners, results were comparable across centres for the language-independent tests. Conclusions: The auditory profile forms a clinical test battery that is applicable in four different languages. Even after baseline correction, differences between test materials have to be taken into account when interpreting results of language-dependent tests in HI listeners.     

以医院为基础的全国多中心女性原发性乳腺癌临床流行病学调查

[目的]利用现有的医院病案资料,开展全国多中心的女性原发性乳腺癌临床流行病学调查,提供肿瘤的临床分期、病理特征以及临床诊治现状等全国性临床流行病学资料,推广简单易行的研究设计,为制定具体防治措施提供临床依据.[方法]按传统地理区域划分中国大陆七个大区,使用便利抽样的方法从每个大区选定一家三级甲等医院;以随机抽样的方式从1999年到2008年每年抽取除1、2月份以外一个月的所有病例进行回顾调查.将研究估算的病例数与医院实际的病例数进行比较;将各大区的女性人口分布与各大区10年累计实际与估算病例数分布进行比较.[结果]所有医院都按统一标准和要求完成了病案摘录,各协作中心的病案摘录合格率都在95.00％以上,总体资料合格率为98.69％;研究估算病例数与实际收治病例数10年间都呈逐年上升的趋势;华北、华南、华东和西北四个大区所选医院对该大区具有较好的代表性.研究估算的病例数与实际收治的病例数在七个大区之间的分布相似.[结论]按大区划分,使用便利抽样与随机抽样相结合的方法抽取的病案资料能够在一定程度上代表总体.样本资料能够反映全国范围内女性原发乳腺癌的临床特征和治疗现状,在现有的人群肿瘤登记资料的基础上为肿瘤的进一步防治提供临床依据.     

Hyperthermia as an adjuvant to radiation therapy of recurrent or metastatic malignant melanoma. A multicentre randomized trial by the European Society for Hyperthermic Oncology

The ESHO protocol 3-85 is a multicentre randomized trial investigating the value of hyperthermia as an adjuvant to radiotherapy in treatment of malignant melanoma. A total of 134 metastatic of recurrent malignant melanoma lesions in 70 patients were randomized to receive radiotherapy alone (3 fractions in 8 days) or each fraction followed by hyperthermia (aimed for 43°C for 60 min). Radiation was given with high voltage photons or electrons. Tumours were stratified according to institution and size (above or below 4 cm) and randomly assigned to a total radiation dose of either 24 or 27 Gy to be given with or without hyperthermia. The endpoint was persistent complete response in the treated area. A number of 128 tumours in 68 patients were evaluable, with an observation time between 3 and 72 months. Sixty-five tumours were randomized to radiation alone and 63 to radiation + heat. Sixty received 24 Gy and 68 tumours received 27 Gy, respectively. Size was ≤4 cm in 81 and >4 cm in 47 tumours. Overall the 2-year actuarial local tumour control was 37%. Univariate analysis showed prognostic influence of hyperthermia (rad alone 28% vs. rad + heat 46%, p = 0.008) and radiation dose (24 Gy 25% vs. 27 Gy 56%, p = 0.02), but not of tumour size (small 42% vs. large 29%, p = 0.21). A Cox multivariate regression analysis showed the most important prognostic parameters to be: hyperthermia (odds ratio: 1.73 (1.07-2.78), p = 0.02), tumour size (odds ratio: 0.91 (0.85-0.99), p = 0.05) and radiation dose (odds ratio: 1.17 (1.01—1.36), p = 0.05). Analysis of the heating quality showed a significant relationship between the extent of heating and local tumour response. Addition of heat did not significantly increase the acute or late radiation reactions. The overall 5-year survival rate of the patients was 19%, but 38% in patients if all known disease was controlled, compared to 8% in the patients with persistent active disease.     

参草通脉颗粒治疗慢性心力衰竭的多中心随机双盲平行对照研究

目的评价参草通脉颗粒治疗慢性心力衰竭[美国纽约心脏病学会(NYHA)分级Ⅱ、Ⅲ级]气虚血瘀水停证的有效性与安全性。方法本研究为多中心、随机、双盲、安慰剂平行对照研究。280例气虚血瘀水停型慢性心力衰竭患者以1∶1比例随机分为试验组和对照组,两组在血管紧张素转化酶抑制剂、利尿剂和地高辛等西药治疗基础上,分别服用参草通脉颗粒或安慰剂,疗程12周。比较两组NYHA心功能分级、中医证候积分和左室射血分数(LVEF),并进行安全性评价。结果共有265例患者完成试验(试验组138例,对照组127例)。治疗后试验组NYHA心功能分级总有效率和中医证候积分总有效率均明显高于对照组(分别为94.20%vs55.90%,97.83%vs70.08%,P<0.01)。两组患者治疗前LVEF比较,差异无统计学意义(P>0.05);与本组治疗前比较,治疗后两组LVEF均明显增加(P<0.05),且试验组LVEF增加值明显大于对照组[(6.55±6.23)%vs(3.14±4.99)%,P<0.05]。两组不良反应发生率均为0.71%(1/140)。结论参草通脉颗粒对NYHA分级属Ⅱ、Ⅲ级的气虚血瘀水停型慢性心力衰竭患者具有良好的疗效,且安全性良好。     

Relations between psychophysical measures of spatial hearing and self-reported spatial-hearing abilities

Objective: The aim of the present study was to investigate how well the virtual psychophysical measures of spatial hearing from the preliminary auditory profile predict self-reported spatial-hearing abilities. Design: Virtual spatial-hearings tests (conducted unaided, via headphones) and a questionnaire were administered in five centres in Germany, the Netherlands, Sweden, and the UK. Correlations and stepwise linear regression models were calculated among a group of hearing-impaired listeners. Study sample: Thirty normal-hearing listeners aged 19–39 years, and 72 hearing-impaired listeners aged 22–91 years with a broad range of hearing losses, including asymmetrical and mixed hearing losses. Results: Several significant correlations (between 0.24 and 0.54) were found between results of virtual psychophysical spatial-hearing tests and self-reported localization abilities. Stepwise linear regression analyses showed that the minimum audible angle (MAA) test was a significant predictor for self-reported localization abilities (5% extra explained variance), and the spatial speech reception threshold (SRT) benefit test for self-reported listening to speech in spatial situations (6% extra explained variance). Conclusions: The MAA test and spatial SRT benefit test are indicative measures of everyday binaural functioning. The binaural SRT benefit test was not found to predict self-reported spatial-hearing abilities.