Abstract：
OBJECTIVE:To assess the impact of including unpublished data on adverse effects in systematic reviews. STUDY DESIGN AND SETTING:We carried out a systematic review of methodological evaluations that compared the quantitative reporting of adverse effects data between published and unpublished sources, in particular, the frequency, rate, or risk of reported adverse effects. Included studies were sought from 10 databases as well as by checking references, handsearching, searching citations, and contacting experts. RESULTS:We identified 6,218 potential articles yielding 10 relevant methodological evaluations. One evaluation found that adverse effects were reported more often in unpublished trials. For anecdotal case reports, two evaluations found a higher frequency of unpublished cases, whereas one study identified a greater number of published cases. Another evaluation indicated that differences in frequency of published and unpublished case reports were topic dependent. A comparison of relative risk estimates from five studies suggested no major systematic variation in risk estimates from published and unpublished studies. CONCLUSION:Inclusion of unpublished studies can provide additional adverse effects information and more precise risk estimates. However, there is insufficient evidence to indicate whether inclusion of unpublished studies has a major influence on the pooled risk estimates in meta-analyses of adverse effects.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Golder S,Loke YK,Bland Mdoi
10.1016/j.jclinepi.2010.02.009subject
Has Abstractpub_date
2010-10-01 00:00:00pages
1071-81issue
10eissn
0895-4356issn
1878-5921pii
S0895-4356(10)00094-6journal_volume
63pub_type
杂志文章,评审abstract：OBJECTIVE:Some authors of Cochrane overviews have also (co-)authored one or more of the underlying reviews. We examined the extent of dual (co-)authorship in Cochrane overviews, how it is dealt with, and whether the issue is raised in protocols. STUDY DESIGN:The Cochrane Library was searched for overviews and protocol...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2016.04.008
更新日期：2016-09-01 00:00:00
abstract：OBJECTIVES:A large body of comparative effectiveness research (CER) focuses on the use of observational and quasi-experimental approaches. We sought to examine the use of clinical trials as a tool for CER, particularly in mental health. STUDY DESIGN AND SETTING:Examination of three ongoing randomized clinical trials i...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2013.02.013
更新日期：2013-08-01 00:00:00
abstract：:Pierre Charles Alexandre Louis (1787-1872) has been the direct or indirect mentor of influential U.S. and English scientists in public health, epidemiology, medicine, and biostatistics during the 19th and 20th century. Louis was primarily a clinician, but his name has been more closely associated with the history of e...
journal_title：Journal of clinical epidemiology
pub_type： 传,历史文章,杂志文章
doi：10.1016/s0895-4356(96)00294-6
更新日期：1996-12-01 00:00:00
abstract：BACKGROUND:Once a proposed topic has been identified for a systematic review and has undergone a question formulation stage, a protocol must be developed that specifies the scope and research questions in detail and outlines the methodology for conducting the systematic review. RATIONALE:Framework modifications are of...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2017.06.013
更新日期：2017-10-01 00:00:00
abstract：:Formulas are derived for determination of the number of patients needed in a prospective comparison of survival curves, when the control group patients have already been followed for some period. Although an explicit formula for the required sample size is not available, the computing is straightforward, and tables of...
journal_title：Journal of clinical epidemiology
pub_type： 临床试验,杂志文章
doi：10.1016/0895-4356(88)90025-x
更新日期：1988-01-01 00:00:00
abstract：OBJECTIVES:How often authors comment on applicability for primary care in systematic reviews of clinical trials. STUDY DESIGN AND SETTING:We selected 4% of the Cochrane Database for Systematic Reviews (CDSRs; January 2008 to October 2013). We excluded reviews when primary care trials were not eligible. We extracted wh...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2015.06.003
更新日期：2015-10-01 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：:To investigate reproductive maternal risk factors of intrapartum fetal asphyxia, we analyzed 556 women with singleton pregnancies complicated by intrapartum fetal asphyxia who gave birth at Kuopio University Hospital from January 1990 to December 1998. The general obstetric population (N=21746) was selected as the ref...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(00)00329-2
更新日期：2001-04-01 00:00:00
abstract：OBJECTIVE:The Mini-Mental State Examination (MMSE) is used to estimate current cognitive status and as a screen for possible dementia. Missing item-level data are commonly reported. Attention to missing data is particularly important. However, there are concerns that common procedures for dealing with missing data, for...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2010.10.011
更新日期：2011-07-01 00:00:00
abstract：OBJECTIVE:Genetic studies of complex human diseases rely heavily on the epidemiologic association paradigm, particularly the population-based case-control designs. This study aims to compare the matching effectiveness in terms of bias reduction between exposure matching and stratum matching. STUDY DESIGN AND SETTING:F...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2008.02.016
更新日期：2009-01-01 00:00:00
abstract：:Time-related aspects of health have attracted increasing interest, and it has become evident that many medical situations concern the exchange of present-day costs for future benefits. Traditional decision analytic paradigms weigh the probability of outcomes and the value of outcomes. Such analyses are incomplete if t...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(02)00447-x
更新日期：2002-09-01 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：OBJECTIVES:The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. STUDY ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2017.07.010
更新日期：2017-11-01 00:00:00
abstract：BACKGROUND AND OBJECTIVE:Two methods for measuring insulin sensitivity, fasting plasma insulin (FPI) and homeostasis model assessment (HOMA) have been proposed for use in large epidemiological research and clinical practice. This project describes the range of observed values of the HOMA and FPI in a large sample of th...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2004.05.001
更新日期：2004-11-01 00:00:00
abstract：OBJECTIVES:To study the statistical power of randomized clinical trials and examine developments over time. STUDY DESIGN AND SETTING:We analyzed the statistical power in 136,212 clinical trials between 1975 and 2014 extracted from meta-analyses from the Cochrane database of systematic reviews. We determined study powe...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2018.06.014
更新日期：2018-10-01 00:00:00
abstract：OBJECTIVES:To explore user perspectives on applying the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to systematic reviews of complex interventions. STUDY DESIGN AND SETTING:Thirty-three authors of recent (2013 onward) systematic reviews were contacted regarding their perspectives on using...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2015.09.010
更新日期：2016-02-01 00:00:00
abstract：OBJECTIVE:To demonstrate how decision analytic models (DAMs) can be used to quantify impact of using a (diagnostic or prognostic) prediction model in clinical practice and provide general guidance on how to perform such assessments. STUDY DESIGN AND SETTING:A DAM was developed to assess the impact of using the HEART s...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2019.07.010
更新日期：2019-11-01 00:00:00
abstract：OBJECTIVE:Optimism bias refers to unwarranted belief in the efficacy of new therapies. We assessed the impact of optimism bias on a proportion of trials that did not answer their research question successfully and explored whether poor accrual or optimism bias is responsible for inconclusive results. STUDY DESIGN:Syst...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2010.09.007
更新日期：2011-06-01 00:00:00
abstract：:This study evaluated the reliability of a new medication appropriateness index. Using the index, independent assessments were made of chronic medications taken by 10 ambulatory, elderly male patients by a clinical pharmacist and an internist-geriatrician. Their overall inter-rater agreement for medication appropriaten...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(92)90144-c
更新日期：1992-10-01 00:00:00
abstract：OBJECTIVE:To develop a questionnaire with which to measure quality of life (QoL) in patients with knee and hip osteoarthritis (OA). STUDY DESIGN AND SETTING:Thirty-two caregivers and 96 OA patients were interviewed individually (using cognitive and face-to-face techniques) and in focus groups. A group of experts worki...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,多中心研究
doi：10.1016/j.jclinepi.2004.04.011
更新日期：2005-01-01 00:00:00
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 p...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(90)90140-k
更新日期：1990-01-01 00:00:00
abstract：:The Program on the Surgical Control of the Hyperlipidemias (POSCH) was a secondary atherosclerosis intervention trial employing partial ileal bypass surgery as the intervention modality. For this report, we analyzed 105 subgroups in 35 variables in POSCH, chosen predominantly for their potential relationship to the ri...
journal_title：Journal of clinical epidemiology
pub_type： 临床试验,杂志文章,多中心研究,随机对照试验
doi：10.1016/0895-4356(94)00145-g
更新日期：1995-03-01 00:00:00
abstract：OBJECTIVE:This study estimated the inter- and intraobserver reliability of a set of noninstrumented physical examination measures for knee pain in older adults. STUDY DESIGN AND SETTING:Forty-five patients from primary care, and 13 patients from secondary care, were each examined by two out of a team of three physical...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2005.11.004
更新日期：2006-05-01 00:00:00
abstract：:To assess the accuracy of Bayesian probability analysis for the prediction of coronary artery disease, post-test probabilities were generated by the application of three Bayesian algorithms to the clinical and noninvasive test results of 199 patients undergoing angiography in a veterans' hospital. All assumed conditio...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(88)90065-0
更新日期：1988-01-01 00:00:00
abstract：OBJECTIVE:To assess the consistency of an index of the scientific quality of research overviews. DESIGN:Agreement was measured among nine judges, each of whom assessed the scientific quality of 36 published review articles. ITEM SELECTION: An iterative process was used to select ten criteria relative to five key tasks...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,meta分析
doi：10.1016/0895-4356(91)90205-n
更新日期：1991-01-01 00:00:00
abstract：:Seasonal plasma lipid and lipoprotein cycles were studied in 1446 hypercholesterolemic 35-59 year-old men followed for 7 years as the placebo group of the Lipid Research Clinics (LRC) Coronary Primary Prevention Trial (CPPT). Separate periodic time series were calculated for each study participant; mean parameter esti...
journal_title：Journal of clinical epidemiology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1016/0895-4356(88)90120-5
更新日期：1988-01-01 00:00:00
abstract：OBJECTIVES:Model specification-what adjusting variables are analytically modeled-may influence results of observational associations. We present a standardized approach to quantify the variability of results obtained with choices of adjustments called the "vibration of effects" (VoE). STUDY DESIGN AND SETTING:We estim...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2015.05.029
更新日期：2015-09-01 00:00:00
abstract：:Despite the great number of methods proposed, assessing the causal role of a drug in the occurrence of an adverse medical event remains one of the most controversial issues. Qualifying terms for criteria, such as "compatible", "suggestive" of "inconclusive", have never been strictly defined, leading to low reproducibi...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(93)90101-6
更新日期：1993-11-01 00:00:00
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：OBJECTIVE:To compare methods commonly used to derive minimal important differences and recommend a rule for defining patients as clinically improved on the low back pain-specific Roland-Morris Disability Questionnaire (RMDQ). METHODS:447 primary care low back pain consulters completed a questionnaire at consultation a...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2005.03.018
更新日期：2006-01-01 00:00:00
