ISSN:1053-8569    

DOI:10.1002/pds.2630030602

出版商:John Wiley&Sons, Ltd.    

年代:1994

数据来源: WILEY

摘要:

AbstractUse of non‐steroidal anti‐inflammatory drugs (NSAIDs) has repeatedly been shown to be associated with a raised risk of ulcer occurrence, hospitalization or complications. Available data suggest that risks may differ significantly between drugs, with diclofenac and ibuprofen appearing to have the lowest associated risks. Clinical treatment strategies should take account of such informat

ISSN:1053-8569    

DOI:10.1002/pds.2630030603

出版商:John Wiley&Sons, Ltd.    

年代:1994

数据来源: WILEY

摘要:

AbstractThis paper gives a short account of the VAMP Research Database which, in the UK, provides information on 4.4 million patients. A number of published and reported examples are given of work conducted on this unique and important pharmacoepidemiological resource.

ISSN:1053-8569    

DOI:10.1002/pds.2630030604

出版商:John Wiley&Sons, Ltd.    

年代:1994

数据来源: WILEY

摘要:

AbstractThe common tools of pharmacoepidemiology are: the spontaneous report registries, the case control study, and the cohort study. Since large sample sizes are usually needed, the classic randomized trial, which collects large amounts of data per patient, seems to be impracticable. Yusufet al.6have suggested using large trials with simple protocols and only minimal data collection to allow for recruitment of large sample sizes (>1000). As the objectives of drug safety studies are not met by the large trial simple protocol design, the large trial, lean protocol design is suggested. Its characteristics are that it is: multicentric, randomized, with no efficacy assessment, recording only baseline, follow‐up and outcome data which are crucial to the primary objective of the trial; there is no ‘by tradition’ collection of data. The indications, the ethics and the biometry of randomized trials with safety variables as major endpoint are discussed.Large trials with a lean protocol are feasible. To illustrate the possible usefulness, a trial will be reported whose primary objective was to assess the rate of a specified adverse event. In general, randomized trials with safety measures as primary endpoints can play an important role in drug risk assessment and their use should be encou

ISSN:1053-8569    

DOI:10.1002/pds.2630030605

出版商:John Wiley&Sons, Ltd.    

年代:1994

数据来源: WILEY

摘要:

AbstractThe ‘Intent to Treat’ paradigm for the analysis of a controlled randomized clinical trial is the direct result of applying the Neyman‐Pearson formulation of hypothesis testing. If other formulations are used, the ‘Intent to Treat’ paradigm makes no sense. Criticisms of the Neyman‐Pearson formulation and whether it is applicable to scientific investigations have appeared in the statistical and philosophical literature since it was first proposed. This paper reviews the nature of that criticism and notes why the Neyman‐Pearson formulation, and with it the ‘Intent to Treat’ paradigm, is inappropriate for use in the analysis o

ISSN:1053-8569    

DOI:10.1002/pds.2630030606

出版商:John Wiley&Sons, Ltd.    

年代:1994

数据来源: WILEY

摘要:

AbstractBackground— Preliminary data suggest that upper respiratory infection diagnoses, but not allergic rhinitis diagnoses, are temporally related to chronic sinusitis diagnoses.Methods— We analysed monthly medical claims (ICD‐9CM codes) for allergic rhinitis, upper respiratory infection and chronic sinusitis for 1990–1991 from three databases: the National Disease and Therapeutic Index (NDTI), the COMPASS Ohio Medicaid and the Blue Cross/Blue Shield of Minnesota (BC/BS‐MN). We also assessed the timing and prevalence of upper respiratory infection, allergic rhinitis and chronic sinusitis in 200 cases from Ohio Medicaid.Results— We found statistically significant positive correlations between upper respiratory infection and chronic sinusitis in NDTI (r= 0.96), Ohio Medicaid (r= 0.95), and BC/BS‐MN (r= 0.92), and statistically significant negative correlations between allergic rhinitis and chronic sinusitis in the NDTI (r= −0.55) and the BC/BS MN data (r= −0.57); the correlation between allergic rhinitis and chronic sinusitis in Ohio data was negative but not significant. Of the 200 sampled chronic sinusitis cases, 51.5% had upper respiratory infection with no allergic rhinitis‐related diagnoses in the previous year; 12.0% had both upper respiratory infection‐ and allergic rhinitis‐related diagnoses and 31% had neither. In the 90 days before chronic sinusitis, 74% of patients ages10 had upper respiratory infection.Conclusions— In these populations, upper respiratory infection diagnoses were closer temporally to chronic sinusitis diagnoses than were allergic rhinitis diagnoses. In the 200 cases, upper respiratory infection was diagnosed more frequently than allergic rhinitis prior to chronic sinusitis. Although not indicative of a cause‐effect relationship, these data suggest that upper respiratory infection may be a more common risk factor than allergic rhi

ISSN:1053-8569    

DOI:10.1002/pds.2630030607

出版商:John Wiley&Sons, Ltd.    

年代:1994

数据来源: WILEY

摘要:

AbstractWe used the automated data files at Group Health Cooperative to identify 1587 outpatient users of oral Talwin, Nx, a combination of pentazocine and naloxone. The clinical records of the Talwin users were reviewed to determine the occurrence of adverse events which were noted in the record in the four weeks after receipt of the drug. The overall rate of adverse events was 8.7 per cent with 6.7 per cent being directly attributed to the effect of Talwin Nx. Gastrointestinal effects were the most common adverse effect and were reported by 3.7 per cent of the patients. Hallucinations, the most serious effect, were experienced by 10 (0.6 per cent) recipients of the drug. None of the subjects in the study had any long‐term effect. Among those who received higher doses, the rate of adverse events was higher than it was for those who received lower doses. Compared to our previous study of oral pentazocine in hospitalized patients, Talwin Nx had a similar rate of hallucinations and a higher rate of gastrointestinal side‐effe

ISSN:1053-8569    

DOI:10.1002/pds.2630030608

出版商:John Wiley&Sons, Ltd.    

年代:1994

数据来源: WILEY

ISSN:1053-8569    

DOI:10.1002/pds.2630030609

出版商:John Wiley&Sons, Ltd.    

年代:1994

数据来源: WILEY

ISSN:1053-8569    

DOI:10.1002/pds.2630030610

出版商:John Wiley&Sons, Ltd.    

年代:1994

数据来源: WILEY

ISSN:1053-8569    

DOI:10.1002/pds.2630030611

出版商:John Wiley&Sons, Ltd.    

年代:1994

数据来源: WILEY