An evaluation of the quality of clinical trials in anesthesia.
Background: The authors evaluated the quality of clinical trials published in four anesthesia journals during the 20-yr period from 1981-2000.Methods: Trials published in four major anesthesia journals during the periods 1981-1985, 1991-1995, and the first 6 months of 2000 were grouped according to...
| Publicado en: | Anesthesiology Vol. 95; no. 5; pp. 1068 - 1074 |
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| Autores principales: | , , , |
| Formato: | research Journal Article |
| Publicado: |
Lippincott Williams & Wilkins
2001 Nov
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=137951640&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 137951640 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00033022 1V8 jtl: Anesthesiology issn: 00033022 maglogo: N pubinfo: dt: 2001 Nov vid: 95 iid: 5 pid: 433 pub: Lippincott Williams & Wilkins place: Baltimore, Maryland artinfo: ui: 137951640 137951640 NLM11684972 137951640 NLM11684972 137951640 ppf: 1068 ppct: 6 formats: tig: atl: An evaluation of the quality of clinical trials in anesthesia. aug: au: Pua, H L Lerman, J Crawford, M W Wright, J G affil: Department of Anaesthesia, The Hospital for Sick Children, Toronto, Ontario, Canada sug: subj: Quality of Health Care Clinical Trials Anesthesiology Sample Size Human Validation Studies Comparative Studies Evaluation Research Multicenter Studies Ferrans and Powers Quality of Life Index Scales ab: Background: The authors evaluated the quality of clinical trials published in four anesthesia journals during the 20-yr period from 1981-2000.Methods: Trials published in four major anesthesia journals during the periods 1981-1985, 1991-1995, and the first 6 months of 2000 were grouped according to journal and year. Using random number tables, four trials were selected from all of the eligible clinical trials in each journal in each year for the periods 1981-1985 and 1991-1995, and five trials were selected from all of the trials in each journal in the first 6 months of 2000. Methods and results sections from the 160 trials from 1981-1985 and 1991-1995 were randomly ordered and distributed to three of the authors for blinded review of the quality of the study design according to 10 predetermined criteria (weighted equally, maximum score of 10): informed consent and ethics approval, eligibility criteria, sample size calculation, random allocation, method of randomization, blind assessment of outcome, adverse outcomes, statistical analysis, type I error, and type II error. After these trials were evaluated, 20 trials from the first 6 months of 2000 were randomly ordered, distributed, and evaluated as described.Results: The mean (+/- SD) analysis scores pooled for the four journals increased from 5.5 +/- 1.4 in 1981-1985 to 7.0 +/- 1.1 in 1991-1995 (P < 0.00001) and to 7.8 +/- 1.5 in 2000. For 7 of the 10 criteria, the percentage of trials from the four journals that fulfilled the criteria increased significantly between 1981-1985 and 1991-1995. During the 20-yr period, the reporting of sample size calculation and method of randomization increased threefold to fourfold, whereas the frequency of type I statistical errors remained unchanged.Conclusion: Although the quality of clinical trials in four major anesthesia journals has increased steadily during the past two decades, specific areas of trial methodology require further attention. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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