ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

A meta-analysis of nine large clinical studies that had looked at a clinical dilemma, which option to use at ‘Step 3 of the British Guidelines on Asthma Management’, was conducted to attempt to determine the better option for adult asthma. All studies had reported results demonstrating superiority of the addition of a long-acting bronchodilator to inhaled corticosteroid for lung function, but, taken singly, none of the studies had sufficient power to provide conclusive evidence on the relative effect of either treatment option on the incidence of asthma exacerbations. However, a carefully conducted meta-analysis of the nine studies was able to provide a conclusive answer to this question. The work was further developed after abstract presentation and subsequently published. This article argues that the pharmaceutical physician is well placed to use this statistical tool more often, but still judiciously, to look at the benefit (or risk) of drugs in development or on the market, and then to act upon that information appropriately.

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

Clinical trials that aim to establish efficacy in the target population need to have an adequate control group. Although scientific principles for efficacy evaluation apply universally, actual choices of control in each region seem to be unique, reflecting differences in regional guidelines for clinical evaluation, preferences of the population, and constraints in study environments. Our survey targeted 76 drugs approved in Japan between April 1999 and July 2000 and showed that active-control was adopted in a significant proportion of controlled phase III trials (74%), while trials with placebo-control accounted for only 18% of the total. The placebo-control was also not so common in phase II (23%). Preference for active-control was observed in many therapeutic fields, but in a few categories such as anti-diabetics placebo-control trials seemed to be the norm. We analysed the possible impact of a new international guideline (ICH-E10) that focuses on the intrinsic defects of active control trial. An economic model suggested that the guideline's introduction could lead to more placebo-control and that the extent of such shift would depend on the increase in cost for active-control trials and possible changes in the requirements for approval. Future patients seem to be major beneficiaries from the new guideline's introduction, considering the history of Japanese efficacy evaluation.

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

We compared the psychometric properties of the McGill Pain Questionnaire (MPQ) with the 17-item Short Pain Inventory© (SPI) in 60 outpatients with osteoarthritic knee pain. Split-half reliability, Guttman split-half reliability, Cronbach alpha and the correlation between the first and second half of the test were higher in the SPI total pain disturbance than any of the summary or subscales of the MPQ: 0.94, 0.94. 0.88 and 0.90, versus 0.71, 0.70, 0.69 and 0.55 for the MPQ sensory present pain intensity, 0.59, 0.57, 0.65 and 0.43 for the affective and 0.62, 0.55, 0.49 and 0.45 for the evaluative MPQ scale, respectively. The parameters for the SPI total mood disturbance were superior to all MPQ-derived scales.Dividing into high and low ‘pain experienced right now’ identified screening samples. The SPI ‘pain right now’ was more discriminating than the comparative MPQ item on both the SPI and MPQ. Additionally, none of the summary scales of the MPQ could show significant internal discrimination whereas the SPI did achieve this.There were 23 significant correlations with the SPI severity compared with 15 with the MPQ. SPI sadness, anxiety, anger, total mood disturbance and total pain disturbance were significantly correlated with the MPQ severity rating. The MPQ variables fared less well than the SPI in the degree of association between various pain parameters and physical severity.Factor analyses revealed that the SPI accounts for the majority of the variance (50%) compared with 17% for Factor 2. This second factor is best indexed by the McGill ‘pain now’ and also with the SPI ‘pain severity now’ item. Since the SPI indexes the severity as accurately (0.79) as the McGill, the only difference between the two is the sensory MPQ variance. However, since the SPI (Factor 1) also indexes some of the common variance of the MPQ sensory variable, the SPI also gains in this respect. If it were the case that the outcome of an analgesic clinical trial was the sensory aspects of the pain (cutting, throbbing, rasping) then the McGill should be the obvious outcome measure. For the patient, the most important feature of pain surely must be the physical severity and the unpleasantness of the experience. The MPQ is a rather long procedure and the evaluative scale is of dubious value. The majority of the pain variance is captured by the SPI and, secondly, by the sensory aspect of the MPQ. The SPI measures the emotional aspects of pain well and the McGill assesses the physical or sensory aspects of pain better than any other available. Both have their place according to one's research interests and the clinical relevance. For example, if an investigation involves opiates like morphine, the SPI may be the better placed instrument, since the induced euphoria may present as a patient who can still feel the pain but is no longer bothered by it. Algesimetry requires measuring both the physical and emotional sensations of the patient.

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS

ISSN:1364-9027    

出版商:ADIS    

年代:2002

数据来源: ADIS