Abstract:
OBJECTIVES:High quality harms data are necessary to appropriately assess the balance between benefits and harms of interventions. Little is known, however, about whether perceived methodological shortcomings are associated with lower estimates of harms. STUDY DESIGN AND SETTING:Studies reporting harms associated with carotid endarterectomy (CEA) and rofecoxib were identified using published systematic reviews. A standardized abstraction form, including eight predefined criteria for assessing the quality of harms reporting, was used to extract data. Univariate and multivariate analyses were performed to empirically evaluate the association between quality criteria and estimates of harms. RESULTS:In 111 studies of CEA, meeting five of the eight-quality criteria was associated with significantly higher adverse event rates. A quality-rating instrument with four criteria predicted adverse events (5.7% in studies rated "adequate," compared to 3.9% in studies rated "inadequate" [P=0.0003]). In multivariate analyses, the quality-rating assignment remained significant when controlling for other clinical and study-related variables. Different quality criteria, however, predicted estimates of risk for myocardial infarction in 16 trials of rofecoxib. CONCLUSION:The presence of methodological shortcomings can predict lower estimates of serious harms. Clinicians and researchers should consider methodological shortcomings when evaluating estimates of harms associated with clinical interventions.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Chou R,Fu R,Carson S,Saha S,Helfand Mdoi
10.1016/j.jclinepi.2006.02.021subject
Has Abstractpub_date
2007-01-01 00:00:00pages
18-28issue
1eissn
0895-4356issn
1878-5921pii
S0895-4356(06)00196-Xjournal_volume
60pub_type
杂志文章,meta分析,评审abstract::Randomized trials are the optimal approach for evaluations of treatment efficacy but may not always be feasible. We study the adequacy of the case-control design in evaluating efficacy in a situation where the investigated therapy, namely the administration of magnesium sulfate for the prevention of eclampsia in patie...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(96)00421-0
更新日期:1997-04-01 00:00:00
abstract::During 1978-1990, 346 patients with sarcoidosis were enrolled in our institute. Of 346 patients, 295 patients were eligible for evaluation on the clinical course and prognosis. According of their clinical presentations, they were classified into 3 groups; severe, moderate and mild sarcoidosis. Of the 295 patients, 27 ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(93)90150-y
更新日期:1993-04-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:To determine the accuracy of recently introduced International Classification of Diseases Ninth Revision (ICD-9) procedure and Current Procedural Terminology (CPT) codes designed for injection or infusion of thrombolytic agents. MATERIALS AND METHODS:We determined the accuracy of ICD-9 procedu...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2006.01.004
更新日期:2006-08-01 00:00:00
abstract:OBJECTIVES:The objective of this study was to analyze adequacy of judgments about risk of bias (RoB) for blinding of participants and personnel (performance bias) in Cochrane systematic reviews of randomized controlled trials (RCTs). STUDY DESIGN AND SETTING:We extracted judgments and supporting comments for performan...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2019.05.012
更新日期:2019-09-01 00:00:00
abstract:OBJECTIVE:To test the effect of postal randomization on recruitment of patients into a randomized trial in primary care. STUDY DESIGN AND SETTING:General practices used a telephone service to randomize patients in our trial. Delays in the start of recruitment at some sites led us to modify the randomization procedure....
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jclinepi.2007.04.003
更新日期:2007-10-01 00:00:00
abstract::The Cochrane Qualitative and Implementation Methods Group develops and publishes guidance on the synthesis of qualitative and mixed-method implementation evidence. Choice of appropriate methodologies, methods, and tools is essential when developing a rigorous protocol and conducting the synthesis. Cochrane authors who...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2017.06.020
更新日期:2018-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:This study describes the conceptual foundation and psychometric properties of the Burden of Stroke Scale (BOSS), a patient-reported health status assessment designed to quantify the physical, cognitive, and psychological burden of stroke. METHODS:Qualitative research methods were used to devel...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2003.11.016
更新日期:2004-10-01 00:00:00
abstract::Several studies show a relationship between abdominal obesity and cardiovascular diseases, partially mediated through an altered metabolism of dyslipidemia. The present study was aimed at testing the robustness of this association across three contrasted populations and at assessing the performances of abdominal obesi...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(99)00184-5
更新日期:2000-04-01 00:00:00
abstract:OBJECTIVE:Hypertension is a risk factor for aortic dissection. Besides hypertension, associated factors for incidence of aortic dissection are not clear. The aim of this study was to examine whether other factors exist by an epidemiologic case-control approach. STUDY DESIGN AND SETTING:240 consecutive cases suffering ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2003.09.010
更新日期:2004-04-01 00:00:00
abstract::Psychosocial factors influencing smoking cessation were studied in current smokers prior to quitting. Two questionnaires were sent in 1975 and 1981 to adult members of the Finnish Twin Cohort. The 1975 response rate was 89%, and 89% of those eligible replied again in 1981. Analysis was done on data from one twin pair ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(88)90088-1
更新日期:1988-01-01 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
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:OBJECTIVE:To assess demographic predictors of response for specialists who were mailed a postal questionnaire on drug treatments for Alzheimer disease. STUDY DESIGN AND SETTING:The questionnaire was sent to 317 specialists in Quebec, Canada. Demographic variables included specialty, urban/rural practice, language, sex...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2003.11.008
更新日期:2004-06-01 00:00:00
abstract:OBJECTIVE:A new strategy to manage conflicts of interests (COIs) of a clinical guideline's panelists gives primary responsibility to a methodologist, puts equal emphasis on intellectual and financial COIs, and excludes panelists with primary conflicts from drafting or voting on recommendations. We explored the views of...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2011.12.013
更新日期:2012-07-01 00:00:00
abstract:OBJECTIVE:To assess measurement equivalence of the Singaporean English and Chinese versions of the EuroQol Group's 5-domain questionnaire (EQ-5D) in cancer patients. STUDY DESIGN AND SETTING:Seven hundred and seventy-one ethnic Chinese patients in Singapore were recruited, and they answered either an English or a Chin...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2008.03.007
更新日期:2009-02-01 00:00:00
abstract::Whereas over the last decade epidemiologic studies on exocrine pancreatic cancer (EPC) continued to show a remarkable heterogeneity in diagnostic criteria applied to define caseness, the actual magnitude and consequences of misclassification remain largely unexplored. The objectives were: (1) to estimate the degree of...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(94)90123-6
更新日期:1994-09-01 00:00:00
abstract:OBJECTIVE:Exposure to ultraviolet radiation has consistently been linked to an increased risk of melanoma. Epidemiologic studies are susceptible to measurement error, which can distort the magnitude of observed effects. Although the reliability of self-report of many sun exposure factors has been previously described i...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2004.09.004
更新日期:2005-04-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to investigate the use of three treatment-effect measures in the analysis of randomized trials using a time-to-event endpoint and assess their influence on the results. STUDY DESIGN AND SETTING:A recent equivalence trial showed discordant results with the use of different measures....
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2017.12.010
更新日期:2018-04-01 00:00:00
abstract:OBJECTIVES:Elderly patients are inordinately affected by surgical site infections (SSIs). This study derived and internally validated a model that used routinely collected health administrative data to measure the probability of SSI in elderly patients within 30 days of surgery. STUDY DESIGN AND SETTING:All people exc...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2016.05.010
更新日期:2016-09-01 00:00:00
abstract:OBJECTIVE:For people with dementia, the concept of quality of life (Qol) reflects the disease's impact on the whole person. Thus, Qol is an increasingly used outcome measure in dementia research. This systematic review was performed to identify available dementia-specific Qol measurements and to assess the quality of l...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2015.08.002
更新日期:2016-02-01 00:00:00
abstract:OBJECTIVE:To provide information concerning the magnitude of the intraclass correlation coefficient (ICC) for cluster-based studies set in primary care. STUDY DESIGN AND SETTING:Reanalysis of data from 31 cluster-based studies in primary care to estimate intraclass correlation coefficients from random effects models u...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.jclinepi.2003.12.013
更新日期:2004-08-01 00:00:00
abstract::In 1984, a prospective cohort study, Coronary Artery Risk Development in Young Adults (CARDIA) was initiated to investigate life-style and other factors that influence, favorably and unfavorably, the evolution of coronary heart disease risk factors during young adulthood. After a year of planning and protocol developm...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(88)90080-7
更新日期:1988-01-01 00:00:00
abstract:OBJECTIVE:Many clinicians and decision makers want to know the combined effects of treatments that have not been evaluated in combination. It is possible to determine such treatment effects by making assumptions about the additive effects. We discuss here the prerequisites and methods of applying additivity assumptions...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2012.07.012
更新日期:2012-12-01 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::Administrative databases are increasingly used for studying outcomes of medical care. Valid inferences from such data require the ability to account for disease severity and comorbid conditions. We adapted a clinical comorbidity index, designed for use with medical records, for research relying on International Classi...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(92)90133-8
更新日期:1992-06-01 00:00:00
abstract::This study aimed to develop a short Osteoporosis-Specific Quality of Life Questionnaire based on the assemblage (equating) of the items of two existing questionnaires (OQLQ and QUALEFFO). For this purpose, each questionnaire was administered by random assignment to a different group of female patients (OQLQ, n = 172; ...
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/s0895-4356(01)00432-2
更新日期:2002-01-01 00:00:00
abstract:OBJECTIVES:The aim of the study was to describe the research environment of scientists in health services and policy research in China. STUDY DESIGN:Study was conducted during the 2016 Westlake Youth Forum with grantees of China Medical Board and key informants. Mixed methods used anonymous, survey of grantees, semist...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2019.05.004
更新日期:2019-08-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:To characterize the impact of multiple Institutional Review Board (IRB) reviews on multicenter observational research studies, and identify strategies for overcoming the identified challenges. MATERIALS AND METHODS:Using PubMed, we identified empirical studies, anecdotal reports, and opinion ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2005.11.018
更新日期:2006-08-01 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:OBJECTIVES:To provide GRADE guidance on how to prepare Summary of Findings tables and Evidence Profiles for time-to-event outcomes with a focus on the calculation of the corresponding absolute effect estimates. STUDY DESIGN AND SETTING:This guidance was justified by a research project identifying frequent errors and l...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2019.10.015
更新日期:2020-02-01 00:00:00