Abstract:
OBJECTIVES:A key systematic review (SR) methodology is comprehensive searching. The Drug Effectiveness Review Project (DERP) SRs search US Food and Drug Administration (FDA) documents to identify unpublished evidence. This study evaluates the success of those efforts. STUDY DESIGN AND SETTING:We examined DERP reports published since 2003 for the use of FDA preapproval and postmarketing documents. We categorized evidence as (1) unique unpublished studies, (2) supplemental unpublished data, or (3) FDA postmarketing data analysis. Three reviewers independently assigned predetermined impact categories (e.g., qualitative or quantitative usage, fills gaps, confirms findings, and alters conclusions), resolving disagreements through consensus. RESULTS:Among 114 DERP reports, 19% included unpublished studies and/or supplemental data and 10% included postmarketing analyses. From 175 preapproval documents, 14% provided eligible unpublished studies and 4.0% supplemental unpublished data that helped confirm previous findings, identify important harms, and fill gaps in knowledge about understudied subpopulations, outcomes, and comparisons. Report conclusion statements changed in 9 of 33 instances of premarketing documents compared with 4 of 12 postmarketing analyses. CONCLUSIONS:The FDA documents can provide important unpublished evidence for SRs, although in a small proportion of cases. Future research should identify attributes that predict which reviews may benefit most from review of FDA documents.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
McDonagh MS,Peterson K,Balshem H,Helfand Mdoi
10.1016/j.jclinepi.2013.05.006subject
Has Abstractpub_date
2013-10-01 00:00:00pages
1071-81issue
10eissn
0895-4356issn
1878-5921pii
S0895-4356(13)00182-0journal_volume
66pub_type
杂志文章,评审abstract:OBJECTIVES:To assess how trial information reported in conference abstracts differs to their subsequent full publication. METHODS:Randomized trials reported at the American Society of Clinical Oncology conference (1992) were identified. CENTRAL and PubMed (December 2002) were searched to identify corresponding full pu...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2005.09.016
更新日期:2006-07-01 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::Trialists argue about the usefulness of stratified randomization. For investigators designing trials and readers who use them, the argument has created uncertainty regarding the importance of stratification. In this paper, we review stratified randomization to summarize its purpose, indications, accomplishments, and a...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/s0895-4356(98)00138-3
更新日期:1999-01-01 00:00:00
abstract::Serum hepatitis C virus (HCV) RNA, HCV genotypes and liver function tests were evaluated in a series of 189 unselected, consecutive anti-HCV positive intravenous drug users (IVDUs). Serum HCV RNA was detected in 106/189 patients. Abnormal liver function tests were associated with alcohol abuse, but not with the presen...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(97)00305-3
更新日期:1998-05-01 00:00:00
abstract::Laparoscopic cholecystectomy was introduced to Western Australia in 1991 and has become the method of choice for this procedure, although there are concerns about complications, particularly bile duct injuries. Previous studies have investigated this problem but have not confirmed the accuracy of coded information. We...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/s0895-4356(99)00043-8
更新日期:1999-09-01 00:00:00
abstract:OBJECTIVES:This study compares three major elements of evidence-based medicine (EBM) practices, namely evidence synthesis, clinical practice guidelines (CPGs), and real-world prescriptions in the United States, regarding antidepressant treatments of major depression over the past 3 decades. STUDY DESIGN AND SETTING:We...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2020.12.023
更新日期:2021-01-06 00:00:00
abstract:OBJECTIVE:Adding risk factors to a prediction model often increases the area under the receiver operating characteristic curve (AUC) only slightly, particularly when the AUC of the model was already high. We investigated whether a risk factor that minimally improves the AUC may nevertheless improve the predictive abili...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2016.07.002
更新日期:2016-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Hui and Walter developed a latent class approach to assess the accuracy of a diagnostic procedure when no reference test is available. Our objective was to compare sensitivity and specificity estimates obtained with this reference-free approach and standard approaches, and to examine how and wh...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2004.10.021
更新日期:2005-07-01 00:00:00
abstract:OBJECTIVE:To assess whether nominally statistically significant effects in meta-analyses of clinical trials are true and whether their magnitude is inflated. STUDY DESIGN AND SETTING:Data from the Cochrane Database of Systematic Reviews 2005 (issue 4) and 2010 (issue 1) were used. We considered meta-analyses with bina...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2010.12.012
更新日期:2011-10-01 00:00:00
abstract:OBJECTIVES:To identify, describe, and map contemporary nutrition guidelines (NGs) from reviews that used the Appraisal of Guidelines, Research and Evaluation (AGREE) tool. STUDY DESIGN AND SETTING:We performed an overview of reviews that systematically assessed the quality of NGs using the AGREE tool. We searched MEDL...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2018.08.018
更新日期:2018-12-01 00:00:00
abstract::The uses of hypothesis in scientific medicine and in clinical medicine are broadly similar; but they differ in subtle but important logical details. The key distinction is that scientific medicine deals with broad ("public") hypotheses about entire populations; and the predominant problem of inference is statistics in...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(89)90028-0
更新日期:1989-01-01 00:00:00
abstract::We studied the relationship between age at natural menopause and total mortality as well as mortality from ischemic heart disease in a cohort of 6182 California Seventh-Day Adventist women who reported a natural menopause. During follow-up from 1976 through 1988, there were 1831 deaths. A total of 308 deaths due to is...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(98)00170-x
更新日期:1999-04-01 00:00:00
abstract::The nature of variability in menstrual function has not been adequately described or quantified across the reproductive life span. This article evaluates the applicability of the bipartite model approach to the analysis of menstrual data and the relative importance of within-woman variability across the reproductive l...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(99)00202-4
更新日期:2000-07-01 00:00:00
abstract:OBJECTIVES:If researchers want to assess reliably different aspects of general health in the migrant populations, they need translations of internationally used health assessment scales with appropriate cross-cultural adaptations and satisfactory psychometric properties. A systematic review was performed to assess the ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2012.12.004
更新日期:2013-06-01 00:00:00
abstract:OBJECTIVES:To determine which factors predict favorable results and positive conclusions in systematic reviews (SRs) and to assess the level of agreement between SR results and conclusions. STUDY DESIGN AND SETTING:A sample of 296 English SRs indexed in MEDLINE (November, 2004) was obtained. Two investigators independ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2008.08.008
更新日期:2009-04-01 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:OBJECTIVE:To describe the pain decrease considered as clinically relevant when designing a trial and reporting its results. METHODS:A systematic review of the literature in MEDLINE was conducted to select randomized controlled trials (RCTs) with pain as a primary outcome. Data extracted included the definition (terms ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2010.06.008
更新日期:2011-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The prospective investigation of repetitive nonfatal suicidal behavior is associated with two methodological problems. Due to the commonly used definitions of nonfatal suicidal behavior, clinical samples usually consist of patients with a considerable between-person variability. Second, repeate...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2005.10.010
更新日期:2006-06-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The determinants of guideline panels' recommendations remain uncertain. The objective of this study was to investigate factors considered by members of 8 panels convened by the American Society of Hematology (ASH) to develop guidelines using Grading of Recommendations Assessment, Development, ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2019.02.009
更新日期:2019-06-01 00:00:00
abstract::In this paper we propose a method and discuss the type of data required to estimate age incidence rates from population survey data. While surveys are typically designed to estimate the prevalence of a disease or medical condition, they can also be used to estimate incidence rates. A limitation of survey data, however...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(89)90100-5
更新日期:1989-01-01 00:00:00
abstract::Period prevalence is frequently measured in studies based on administrative data such as that from health maintenance organizations. For example, treated prevalence and drug utilization prevalence are important measures that are typically defined in relationship to a specified time period. Often one wishes to compare ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/0895-4356(95)00573-0
更新日期:1996-04-01 00:00:00
abstract::A summary performance measure comprised of a hierarchical balance task, a 4-meter walk, and five repetitive chair stands is increasingly being used as a predictor of independent living for older persons. The reliability and sensitivity to change of this summary performance measure have not been investigated, however. ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(02)00436-5
更新日期:2002-09-01 00:00:00
abstract:OBJECTIVES:Procedures for controlling the false positive rate when performing many hypothesis tests are commonplace in health and medical studies. Such procedures, most notably the Bonferroni adjustment, suffer from the problem that error rate control cannot be localized to individual tests, and that these procedures d...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2014.03.012
更新日期:2014-08-01 00:00:00
abstract:OBJECTIVES:The Osteoarthritis Questionnaire (OA-Quest) is a new measure of individual burden of osteoarthritis, composing seven brief (4-11 items; total 42 items), independent scales. This study describes the psychometric evaluation of the OA-Quest. Specifically, temporal stability, convergent and discriminant validity...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2019.06.001
更新日期:2019-10-01 00:00:00
abstract:BACKGROUND:There is no population-based prospective study concerning the relation between serum albumin and mortality in a non-Western population, and few previous studies included the subgroup analysis stratified by serum cholesterol level. METHODS:A 13.7-year cohort study was conducted on 6,957 males and females age...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2004.02.019
更新日期:2004-11-01 00:00:00
abstract:OBJECTIVES:To systematically evaluate the use of Framingham Risk Score (FRS) in the medical literature and specifically examine the use of FRS in different populations and settings and for different outcomes than the ones originally developed for. STUDY DESIGN AND SETTING:We identified all the citations to the article...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2013.10.021
更新日期:2014-05-01 00:00:00
abstract::The effect of gender and other clinical variables on short-term and long-term cardiac mortality after a first transmural myocardial infarction (MI) was assessed in a population-based hospital register. A cohort of 1216 consecutive patients (1023 men and 193 women), 25-74 years old admitted to the only reference hospit...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(94)90016-7
更新日期:1994-02-01 00:00:00
abstract::Moderate consumers of alcohol have lower mortality than either nondrinkers or heavy drinkers. This systematic review aimed to quantify the level of alcohol consumption (termed the nadir) at which the lowest mortality occurs. Twenty cohort studies reported analyses of all-cause mortality for at least three categories o...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,meta分析
doi:10.1016/s0895-4356(99)00076-1
更新日期:1999-10-01 00:00:00
abstract:OBJECTIVES:To evaluate whether noninferiority trials are designed to adequately preserve the historical treatment effect of their active comparators. STUDY DESIGN AND SETTING:We reviewed 162 noninferiority trials published in high-impact medical journals. We assessed whether trials were designed to ensure that interve...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2019.03.003
更新日期:2019-06-01 00:00:00
abstract:BACKGROUND:Longitudinal studies estimating the association between disability and mortality in the elderly population have typically assumed disability constant through the follow-up study period. Current knowledge indicates that such assumptions may not be appropriate. Our purpose was to examine this association (disa...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(03)00201-4
更新日期:2003-12-01 00:00:00