Abstract:
OBJECTIVES:The objective of this study was to determine whether disagreements among multiple data sources affect systematic reviews of randomized clinical trials (RCTs). STUDY DESIGN AND SETTING:Eligible RCTs examined gabapentin for neuropathic pain and quetiapine for bipolar depression, reported in public (e.g., journal articles) and nonpublic sources (clinical study reports [CSRs] and individual participant data [IPD]). RESULTS:We found 21 gabapentin RCTs (74 reports, 6 IPD) and 7 quetiapine RCTs (50 reports, 1 IPD); most were reported in journal articles (18/21 [86%] and 6/7 [86%], respectively). When available, CSRs contained the most trial design and risk of bias information. CSRs and IPD contained the most results. For the outcome domains "pain intensity" (gabapentin) and "depression" (quetiapine), we found single trials with 68 and 98 different meta-analyzable results, respectively; by purposefully selecting one meta-analyzable result for each RCT, we could change the overall result for pain intensity from effective (standardized mean difference [SMD] = -0.45; 95% confidence interval [CI]: -0.63 to -0.27) to ineffective (SMD = -0.06; 95% CI: -0.24 to 0.12). We could change the effect for depression from a medium effect (SMD = -0.55; 95% CI: -0.85 to -0.25) to a small effect (SMD = -0.26; 95% CI: -0.41 to -0.1). CONCLUSIONS:Disagreements across data sources affect the effect size, statistical significance, and interpretation of trials and meta-analyses.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Mayo-Wilson E,Li T,Fusco N,Bertizzolo L,Canner JK,Cowley T,Doshi P,Ehmsen J,Gresham G,Guo N,Haythornthwaite JA,Heyward J,Hong H,Pham D,Payne JL,Rosman L,Stuart EA,Suarez-Cuervo C,Tolbert E,Twose C,Vedula S,Dickedoi
10.1016/j.jclinepi.2017.07.014subject
Has Abstractpub_date
2017-11-01 00:00:00pages
95-110eissn
0895-4356issn
1878-5921pii
S0895-4356(17)30721-7journal_volume
91pub_type
杂志文章,评审abstract:OBJECTIVE:To develop a tool for identifying and quantifying morbidity following cardiac surgery (cardiac postoperative morbidity score [C-POMS]). STUDY DESIGN AND SETTING:Morbidity was prospectively assessed in 450 cardiac surgery patients on postoperative days 1, 3, 5, 8, and 15 using POMS criteria (nine postoperativ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2011.11.004
更新日期:2012-04-01 00:00:00
abstract::Occasionally, the efficacy of screening for cancer recurrence has been evaluated by means of case-control studies. However, these studies generally have not been designed and analyzed in a manner that will yield an unbiased result. The commentary shows that by adhering to the principles developed for the analysis of s...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2010.07.013
更新日期:2011-01-01 00:00:00
abstract:OBJECTIVE:To validate the prognostic accuracy of a previously proposed comorbidity index using information of a different and separate population-based cohort. STUDY DESIGN AND SETTING:We assessed the predictive accuracy of a comorbidity index to predict mortality by looking at calibration and discrimination in the de...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2007.09.006
更新日期:2008-08-01 00:00:00
abstract:OBJECTIVES:The receiver operating characteristic curves (ROC curves) are often used to compare continuous diagnostic tests or determine the optimal threshold of a test; however, they do not consider the costs of misclassifications or the disease prevalence. The ROC graph was extended to allow for these aspects. STUDY ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2015.01.003
更新日期:2015-07-01 00:00:00
abstract:OBJECTIVES:The objective of this study was to identify and describe critical appraisal tools designed for assessing the quality of evidence (QoE) and/or strength of recommendations (SoRs) related to health care-related tests and diagnostic strategies (HCTDSs). STUDY DESIGN AND SETTING:We conducted a systematic review ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2017.09.007
更新日期:2017-12-01 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::Three acute coronary care surveys (1986, 1990, and 1993) were conducted in the Swiss region of Vaud-Fribourg on all men aged 25 to 64 years hospitalized for a definite myocardial infarction (218, 224, and 167 cases). Nearly all patients received anticoagulants and nitrates. The proportion of patients treated increased...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(98)00049-3
更新日期:1998-09-01 00:00:00
abstract::This paper focuses on the appropriateness of outcome measures to evaluate trauma care. The preventable death rate (PDR), based on the study of deceased patients only, has been the traditional measure of the impact of trauma care on improving the survival of patients with severe trauma. Another measure frequently used ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(90)90125-9
更新日期:1990-01-01 00:00:00
abstract:OBJECTIVES:Disinvestment is critical for ensuring the long-term sustainability of health-care services. Key barriers to disinvestment are heterogeneity between research and clinical settings, absence of evidence of effectiveness of some health technologies, and exposure of patients and organizations to risks and poor o...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2013.08.014
更新日期:2014-02-01 00:00:00
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:BACKGROUND:The impact of disease on population health is most commonly estimated by the population attributable fraction (PAF), or less commonly by the excess risk, an alternative measure that estimates the absolute risk of disease in the population that can be ascribed to the exposure. Using chronic airflow obstructio...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2017.10.020
更新日期:2018-01-01 00:00:00
abstract::The occurrence and number of melanocytic nevi are among the most important known risk factors for the development of malignant melanoma. Studying the causes of nevi should lead to successful strategies in the prevention of melanoma. Among 11,478 white German children of preschool age the association between benign mel...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(02)00484-5
更新日期:2002-11-01 00:00:00
abstract::The utility of ordinal logistic regression in the prediction of colorectal neoplasia was demonstrated in a group of 461 consecutive patients undergoing colonoscopy in a community practice. One hundred twenty-nine patients had adenomatous polyps and 34 had colorectal adenocarcinoma. An ordinal logistic regression model...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(91)90159-7
更新日期:1991-01-01 00:00:00
abstract:OBJECTIVES:Constructs capturing health or functioning can have reflective and/or formative measurement models. Although a construct's measurement model has extensive implications on the construction, validation, and use of a measurement instrument, measurement models are frequently wrongly or not explicitly specified. ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2018.07.007
更新日期:2018-11-01 00:00:00
abstract::To compare Charlson indices based on chart data and ICD-9 data for agreement overall and on rating specific comorbid conditions, and to compare mortality risks associated with these indices. Prospective cohort study. Six general medicine wards at Yale-New Haven Hospital. 524 consecutive patients who had no clinical ev...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(00)00367-x
更新日期:2001-07-01 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::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::The duration of protection offered by Pap screening for cervical cancer was examined using data on 101 cases of invasive cervical cancer and 396 controls from a Maryland case-control study. Receipt of a Pap test up to 4 years ago afforded significant protection, compared to women screened 11 or more years ago, or neve...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(89)90166-2
更新日期:1989-01-01 00:00:00
abstract:OBJECTIVE:We aimed to determine to what extent covariate adjustment could affect power in a randomized controlled trial (RCT) of a heterogeneous population with traumatic brain injury (TBI). STUDY DESIGN AND SETTING:We analyzed 14-day mortality in 9,497 participants in the Corticosteroid Randomization After Significan...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.jclinepi.2011.08.012
更新日期:2012-05-01 00:00:00
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 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 ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2013.05.006
更新日期:2013-10-01 00:00:00
abstract::The microbial flora on the surfaces of 15 books obtained from a public library and from 15 books obtained from a family household were studied. Staphylococcus epidermidis was recovered from 4 of the library books and 3 of the family household books. The number of organisms per page was between one to four. This data i...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(94)90103-1
更新日期:1994-10-01 00:00:00
abstract:OBJECTIVE:To develop a culturally adapted Bengali version of the Short Form-36 (SF-36) Health Survey and to test its acceptability, reliability, and validity in patients with rheumatoid arthritis (RA). STUDY DESIGN AND SETTING:The US English SF-36 was translated into Bengali after established cross-cultural adaptation...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2012.05.004
更新日期:2012-11-01 00:00:00
abstract::From a database of 93,077 in-patient admissions, patients assigned to catastrophic, very severe, moderately severe, and average 30-day mortality risk categories (as defined in Medicare Hospital Mortality Information, 1989 release, from the Health Care Financing Administration (HCFA] were selected for study. These admi...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(91)90100-n
更新日期:1991-01-01 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::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::The purpose of this study was to describe patterns of health care use by inner-city patients with asthma and to identify patients at risk for hospitalization. We performed a retrospective cohort study of 1788 patients with asthma aged 5 to 34 years from a large hospital-based multi-specialty practice in inner-city Ind...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(96)00333-2
更新日期:1997-02-01 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:OBJECTIVE:Estimates of minimal clinically important improvements (MCIIs) are larger among patients with higher values at baseline, suggesting that these patients require larger changes to appreciate improvements. We examined if baseline dependency of MCIIs was associated with specific patients across three measures, or...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2013.10.025
更新日期:2014-06-01 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