Abstract：
:Event monitoring was first suggested 25 years ago as a way of detecting adverse reactions to drugs. Prescription-event monitoring (PEM), which has been developed by the Drug Safety Research Unit, is the first large-scale systematic post-marketing surveillance method to use event monitoring in the U.K. PEM identifies patients, who have been prescribed a particular drug, and their doctors from photocopies of National Health Service prescriptions which are processed centrally in England. A personalized follow-up questionnaire ("green form") is mailed to each patient's general practitioner, usually on the first anniversary of the initial prescription, asking for information about the patient, especially any "events" that he or she may have experienced since beginning treatment with the drug. The methodology of PEM is presented, together with examples of analyses that can be performed using results from recent studies. The problems and benefits of PEM are discussed.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Rawson NS,Pearce GL,Inman WHdoi
10.1016/0895-4356(90)90140-ksubject
Has Abstractpub_date
1990-01-01 00:00:00pages
509-22issue
5eissn
0895-4356issn
1878-5921pii
0895-4356(90)90140-Kjournal_volume
43pub_type
杂志文章abstract：OBJECTIVES:Meta-analyses inform clinical practice by summarizing treatment effect estimates based on results from several trials. However, the statistical significance of a meta-analysis (i.e., whether the pooled treatment effect is statistically significant or not) may rely on the outcome of only a few patients from s...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2019.03.012
更新日期：2019-07-01 00:00:00
abstract：:Application of sequential analysis may avoid unnecessary experimentation and achieve economical use of available biomaterial stored in biological banks. When, as often happens in cohort case-controls studies, cases are scarce, it may be possible to use multiple control observations per case to increase the power of a ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(93)90073-a
更新日期：1993-03-01 00:00:00
abstract：:The Busselton Survey is a population survey that is held about every three years. In 1994-1995 a re-survey was held of all past participants and 8,502 attended. Financial constraints precluded employing staff for data collection for blood pressure and anthropometry, these therefore were collected by unpaid lay volunte...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(01)00492-9
更新日期：2002-04-01 00:00:00
abstract：OBJECTIVES:To investigate whether the relationship between demographic and disease-related variables and disability is constant during the first five years of inflammatory polyarthritis (IP) and to identify the contribution from involvement of specific joint areas to overall disability. METHODS:684 patients referred t...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(00)00189-x
更新日期：2000-10-01 00:00:00
abstract：:Mortality rates of 22,995 Finnish men aged 25 and over followed up for a median of 12 years were analyzed in relation to body mass index (BMI) at the initial examination. All-cause mortality followed a "U"-shaped distribution, being greatest for the thinnest and fattest men at all ages, or about 1.5-fold for those wit...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(89)90076-0
更新日期：1989-01-01 00:00:00
abstract：OBJECTIVES:The objective of this study was to assess if there is evidence of publication bias in prognostic accuracy studies of middle cerebral artery (MCA) or cerebroplacental ratio (CPR) for adverse perinatal outcome. STUDY DESIGN AND SETTING:We queried PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov an...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2019.07.016
更新日期：2019-12-01 00:00:00
abstract：:Dupuytren's disease or palmar fibromatosis is a common disabling hand disorder, mainly confined to Caucasians of northwestern European origin. The prevalence of Dupuytren's disease and possible risk factors related to the disease were evaluated in a random sample of 1297 males and 868 females, aged 46 to 74 years. Blo...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(99)00145-6
更新日期：2000-03-01 00:00:00
abstract：OBJECTIVES:The aim of this study was to evaluate how often the European Medicines Agency (EMA) has authorized drugs based on nonrandomized studies and whether there is an association between treatment effects and EMA preference for further testing in randomized clinical trials (RCTs). STUDY DESIGN AND SETTING:We revie...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2018.01.011
更新日期：2018-06-01 00:00:00
abstract：OBJECTIVE:To determine the frequency of unpublished systematic reviews (SRs) and explore factors contributing to their occurrence. STUDY DESIGN AND SETTING:First or corresponding authors from a sample of SRs published in 2005 were asked to participate in a 26-item survey administered through the Internet, facsimile, a...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2008.09.014
更新日期：2009-06-01 00:00:00
abstract：OBJECTIVES:To present a new method to estimate a "minimal important change" (MIC) of health-related quality of life (HRQOL) scales, based on predictive modeling, and to compare its performance with the MIC based on receiver operating characteristic (ROC) analysis. To illustrate how the new method deals with variables t...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2015.03.015
更新日期：2015-12-01 00:00:00
abstract：:Results from pragmatic trials should reflect the comparative treatment effects encountered in patients in real-life clinical practice to guide treatment decisions. Therefore, pragmatic trials should focus on outcomes that are relevant to patients, clinical practice, and treatment choices. This sixth article in the ser...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2016.12.022
更新日期：2017-10-01 00:00:00
abstract：:The objective of this study was to assess whether trials with a positive (i.e., statistically significant) outcome are cited more often than negative trials. We reviewed 530 randomized clinical trials on hepato-biliary diseases published in 11 English-language journals indexed in MEDLINE from 1985-1996. From each tria...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(01)00513-3
更新日期：2002-04-01 00:00:00
abstract：OBJECTIVES:To revise 2010 guidance on grading the strength of evidence (SOE) of the effectiveness of drugs, devices, and other preventive and therapeutic interventions in systematic reviews produced by the Evidence-based Practice Center (EPC) program, established by the US Agency for Healthcare Research and Quality (AH...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2014.11.023
更新日期：2015-11-01 00:00:00
abstract：OBJECTIVE:The purpose of this study was to examine the proportion of men who died from prostate cancer (PrCa) vs. with PrCa and assess the comorbid conditions associated with other-cause deaths. STUDY DESIGN AND SETTING:We identified all male decedents aged >/=65 years in Jefferson County, AL, in 1993-1995. By crossli...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2003.11.009
更新日期：2004-07-01 00:00:00
abstract：OBJECTIVE:Graphical methods for generating explanatory hypotheses from limited categorical data are described and illustrated. STUDY DESIGN AND SETTING:Univariate, bivariate, multivariate, and multiplicative graphical methods were applied to clinical data regarding very ill older persons. The data to which these metho...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2011.06.007
更新日期：2012-02-01 00:00:00
abstract：:We analyzed data from outpatients with chronic low back pain (LBP) in the Veterans Health Study (n = 563) to examine the relationship between localized LBP intensity and radiating leg pain in assessing patient functional status, low back disability, and use of diagnostic imaging. Based on the localized LBP intensity, ...
journal_title：Journal of clinical epidemiology
pub_type： 临床试验,杂志文章,多中心研究
doi：10.1016/s0895-4356(99)00094-3
更新日期：1999-11-01 00:00:00
abstract：OBJECTIVE:This cohort study investigated potential clinical and biochemical predictors of subsequent preterm birth in women presenting with threatened preterm labor. STUDY DESIGN AND SETTING:Subjects were 218 pregnant women admitted to hospital with a diagnosis of threatened preterm labor at 22-36 weeks gestation. Exc...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2004.06.015
更新日期：2005-03-01 00:00:00
abstract：INTRODUCTION:Weight loss interventions often present small mean weight changes over time, despite the fact that a substantial proportion of the participants lost more weight. This effect is often leveled out by the substantial proportion of participants who gained weight during the trial. The aim of this study is to id...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.jclinepi.2014.03.007
更新日期：2014-08-01 00:00:00
abstract：BACKGROUND AND OBJECTIVE:To test unidimensionality and local independence of a set of shoulder functional status (SFS) items, develop a computerized adaptive test (CAT) of the items using a rating scale item response theory model (RSM), and compare discriminant validity of measures generated using all items (theta(IRT)...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2005.08.006
更新日期：2006-03-01 00:00:00
abstract：:Measuring the effectiveness of cognitive rehabilitation programs poses both conceptual and practical challenges. We compared several standardized outcome measures with goal attainment scaling (GAS) to assess their sensitivity to changes in health status in patients undergoing cognitive rehabilitation. GAS is a measure...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(97)00014-0
更新日期：1997-05-01 00:00:00
abstract：OBJECTIVE:To examine the impact of changes in comorbidity--as measured by the Charlson comorbidity index--on self-rated health in a large sample of community-dwelling elderly over a 1-year period, and to examine the differential effects of changes in specific Charlson diagnostic categories. STUDY DESIGN AND SETTING:Lo...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2008.05.009
更新日期：2009-02-01 00:00:00
abstract：:The Apgar score is widely used for several purposes: to discriminate between infants who require resuscitation at birth and those who do not; to predict outcome; and to evaluate change in the condition of the newly born over the first minutes of life. Using published evidence of its clinical reliability and validity, ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(88)90100-x
更新日期：1988-01-01 00:00:00
abstract：:Differential recall between compared groups is discussed most often in the context of case-control studies. Cases, compared to controls, are suspected of providing a more complete report of their true exposure to an hypothesized risk factor, thereby biasing upwards the estimate of its effect. The present paper describ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(90)90100-4
更新日期：1990-01-01 00:00:00
abstract：:Although developed societies have undergone many profound changes during recent decades, including urbanization, increased traffic and aging of the populations, epidemiologic information on secular trends in profiles of injuries is limited. We investigated such trends in Finland by selecting from the National Hospital...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(00)00346-2
更新日期：2001-06-01 00:00:00
abstract：OBJECTIVE:The aim of the study was to consider statistical and methodological issues affecting the results of meta-analysis of genetic association studies for pertinent gene-disease associations. Although the basic statistical issues for performing meta-analysis are well described in the literature, there are remaining...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2007.12.011
更新日期：2008-07-01 00:00:00
abstract：BACKGROUND AND OBJECTIVE:There is a pressing need for evidence-based interventions to address the devastating clinical and public health effects of the coronavirus disease 2019 (COVID-19) pandemic. The number of registered trials related to COVID-19 is increasing by the day. The objective of this study was to describe ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2020.06.005
更新日期：2020-09-01 00:00:00
abstract：OBJECTIVE:To address methodologic issues in searching for observational studies by presenting database search methods and results. STUDY DESIGN AND SETTING:Results of two literature searches for publications reporting on observational studies of alcohol consumption and the risk of breast cancer and large bowel cancer ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2005.03.004
更新日期：2005-09-01 00:00:00
abstract：OBJECTIVES:Adjudication committees (ACs) are recommended in randomized controlled trials (RCTs) to standardize the assessment of events. We aimed to assess the reporting and functioning of ACs (synonyms: clinical event committees, endpoint committees) in clinical trials. STUDY DESIGN AND SETTING:We searched five high-...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2008.09.011
更新日期：2009-07-01 00:00:00
abstract：OBJECTIVE:This study examines the effects of telephone and mail interview methods on the measurement of health-related quality of life. STUDY DESIGN AND SETTING:One thousand six hundred ninety individuals aged 25-66 were interviewed randomly either by telephone or by mail. Health-related quality of life was assessed w...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.jclinepi.2007.12.003
更新日期：2008-10-01 00:00:00
abstract：OBJECTIVES:To evaluate how the rank probabilities obtained from network meta-analysis (NMA) change with the use of increasingly stringent criteria for the relative effect comparing two treatments which ranks one treatment better than the other. STUDY DESIGN AND SETTING:Systematic survey and reanalysis of published dat...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2018.02.008
更新日期：2018-06-01 00:00:00
