Nonrandomized studies using causal-modeling may give different answers than RCTs: a meta-epidemiological study.

Abstract:

OBJECTIVES:To evaluate how estimated treatment effects agree between nonrandomized studies using causal modeling with marginal structural models (MSM-studies) and randomized trials (RCTs). STUDY DESIGN:Meta-epidemiological study. SETTING:MSM-studies providing effect estimates on any healthcare outcome of any treatment were eligible. We systematically sought RCTs on the same clinical question and compared the direction of treatment effects, effect sizes, and confidence intervals. RESULTS:The main analysis included 19 MSM-studies (1,039,570 patients) and 141 RCTs (120,669 patients). MSM-studies indicated effect estimates in the opposite direction from RCTs for eight clinical questions (42%), and their 95% CI (confidence interval) did not include the RCT estimate in nine clinical questions (47%). The effect estimates deviated 1.58-fold between the study designs (median absolute deviation OR [odds ratio] 1.58; IQR [interquartile range] 1.37 to 2.16). Overall, we found no systematic disagreement regarding benefit or harm but confidence intervals were wide (summary ratio of odds ratios [sROR] 1.04; 95% CI 0.88 to 1.23). The subset of MSM-studies focusing on healthcare decision-making tended to overestimate experimental treatment benefits (sROR 1.44; 95% CI 0.99 to 2.09). CONCLUSION:Nonrandomized studies using causal modeling with MSM may give different answers than RCTs. Caution is still required when nonrandomized "real world" evidence is used for healthcare decisions.

journal_name

J Clin Epidemiol

authors

Ewald H,Ioannidis JPA,Ladanie A,Mc Cord K,Bucher HC,Hemkens LG

doi

10.1016/j.jclinepi.2019.10.012

subject

Has Abstract

pub_date

2020-02-01 00:00:00

pages

29-41

eissn

0895-4356

issn

1878-5921

pii

S0895-4356(19)30263-X

journal_volume

118

pub_type

杂志文章,评审
  • Educational attainment and osteoarthritis: differential associations with radiographic changes and symptom reporting.

    abstract::Educational attainment has been negatively associated with the prevalence, morbidity and mortality of many diseases. With knee osteoarthritis as an example, we used NHANES I data to examine whether the cross-sectional association between formal education and disease is due to known risk factors, and also whether educa...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(92)90006-9

    authors: Hannan MT,Anderson JJ,Pincus T,Felson DT

    更新日期:1992-02-01 00:00:00

  • Between iatrotropic stimulus and interiatric referral: the domain of primary care research.

    abstract::The "iatrotropic stimulus" is a typical example of Alvan Feinstein's terminology and his clinical way of thinking about medical research. Feinstein specified "interiatric referral" as an additional important factor affecting "the likelihood that patients will appear at the particular setting in which research is being...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/s0895-4356(02)00528-0

    authors: Knottnerus JA

    更新日期:2002-12-01 00:00:00

  • Test-retest of self-reported exposure to artificial tanning devices, self-tanning creams, and sun sensitivity showed consistency.

    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

    authors: Beane Freeman LE,Dennis LK,Lynch CF,Lowe JB,Clarke WR

    更新日期:2005-04-01 00:00:00

  • A simulation study into the performance of "optimal" diagnostic thresholds in the population:"Large" effect sizes are not enough.

    abstract:OBJECTIVES:Many diagnostic studies are aimed at defining "optimal" thresholds. Here, we evaluate the performance of empirically defined optimal thresholds (1) in the sample in which they were defined and (2) in the population from which the sample was drawn. STUDY DESIGN AND SETTING:We simulated test results for 120,0...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2013.07.018

    authors: Hirschfeld G,do Brasil PE

    更新日期:2014-04-01 00:00:00

  • WHO/ISH total risk approach for primary prevention of cardiovascular disease shows greater decrease in costs for women but not the elderly in Jamaica.

    abstract:OBJECTIVES:To investigate cost savings from and implications of replacing the single risk with a total cardiovascular risk approach in primary prevention of cardiovascular disease (CVD). STUDY DESIGN AND SETTING:A cost analysis using data from the 2007-08 Jamaica Health and Lifestyle Survey of 1,432 persons aged 40 ye...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2014.11.027

    authors: Abdulkadri AO,Tulloch-Reid MK,Francis DK,Gordon-Strachan GM,Younger-Coleman NO,Rocke KD,McFarlane SR,Cunningham-Myrie CA,Ferguson TS,Wilks RJ,Anderson SG

    更新日期:2015-09-01 00:00:00

  • Increased risks for random errors are common in outcomes graded as high certainty of evidence.

    abstract:OBJECTIVES:The aim of article was to assess the risk for random errors in outcomes graded as high certainty of evidence (CoE). STUDY DESIGN AND SETTING:We randomly selected 100 Cochrane reviews with dichotomous outcomes rated as high CoE using Grading of Recommendations Assessment, Development, and Evaluation. To dete...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2018.10.009

    authors: Gartlehner G,Nussbaumer-Streit B,Wagner G,Patel S,Swinson-Evans T,Dobrescu A,Gluud C

    更新日期:2019-02-01 00:00:00

  • Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases.

    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

    authors: Deyo RA,Cherkin DC,Ciol MA

    更新日期:1992-06-01 00:00:00

  • Measuring health status using the Health Utilities Index: agreement between raters and between modalities of administration.

    abstract::The aim of this study was to evaluate interrater and intermodality agreement in assessing health status using the Health Utilities Index. A random sample from a Dutch cohort of 14-year-old Very Low Birth Weight children and their parents were invited to participate in a face-to-face (n = 150) or telephone (n = 150) in...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/s0895-4356(00)00317-6

    authors: Verrips GH,Stuifbergen MC,den Ouden AL,Bonsel GJ,Gemke RJ,Paneth N,Verloove-Vanhorick SP

    更新日期:2001-05-01 00:00:00

  • The impact of changes in coffee consumption on serum cholesterol.

    abstract::To investigate the possible association between changes in coffee consumption and serum cholesterol levels, information was obtained from 2109 healthy nonsmokers aged 25-65 years at two clinic visits to a preventive medical center between 1987 and 1991 (mean interval between visits: 16.7 months). After adjusting for a...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(95)00023-w

    authors: Wei M,Macera CA,Hornung CA,Blair SN

    更新日期:1995-10-01 00:00:00

  • STrengthening the Reporting of OBservational studies in Epidemiology--Molecular Epidemiology STROBE-ME: an extension of the STROBE statement.

    abstract::Advances in laboratory techniques have led to a rapidly increasing use of biomarkers in epidemiological studies. Biomarkers of internal dose, early biological change susceptibility and clinical outcomes are used as proxies for investigating the interactions between external and/or endogenous agents and body components...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2011.07.010

    authors: Gallo V,Egger M,McCormack V,Farmer PB,Ioannidis JP,Kirsch-Volders M,Matullo G,Phillips DH,Schoket B,Stromberg U,Vermeulen R,Wild C,Porta M,Vineis P

    更新日期:2011-12-01 00:00:00

  • Systematic reviews of test accuracy should search a range of databases to identify primary studies.

    abstract:OBJECTIVE:To estimate the yield from searching a range of bibliographic databases and additional sources to identify test accuracy studies for systematic reviews. STUDY DESIGN AND SETTING:We examined eight systematic reviews and their database searches: MEDLINE, EMBASE, BIOSIS, Science Citation Index, LILACS, Pascal, ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2007.05.013

    authors: Whiting P,Westwood M,Burke M,Sterne J,Glanville J

    更新日期:2008-04-01 00:00:00

  • Parity derived for pregnant women using historical administrative hospital data: accuracy varied among patient groups.

    abstract:OBJECTIVES:Understanding patterns of maternity care requires knowing which women have given birth previously, but this information is typically unavailable in administrative hospital data sets. We assessed how well parity can be derived using linked historical records. STUDY DESIGN AND SETTING:Using Hospital Episode S...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2013.10.011

    authors: Cromwell DA,Knight HE,Gurol-Urganci I

    更新日期:2014-05-01 00:00:00

  • A study of the noninstrumented physical examination of the knee found high observer variability.

    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

    authors: Wood L,Peat G,Wilkie R,Hay E,Thomas E,Sim J

    更新日期:2006-05-01 00:00:00

  • The development of a postoperative morbidity score to assess total morbidity burden after cardiac surgery.

    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

    authors: Sanders J,Keogh BE,Van der Meulen J,Browne JP,Treasure T,Mythen MG,Montgomery HE

    更新日期:2012-04-01 00:00:00

  • Examination by logistic regression modelling of the variables which increase the relative risk of elderly women falling compared to elderly men.

    abstract::In a community based, prospective study to determine risk factors for falls, 465 women and 296 men 70 years and over were followed for 1 year and 507 falls were documented. A greater proportion of women (32.7%) than men (23.0%) experienced at least one fall in which there was no or minimal external contribution. Using...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(90)90110-b

    authors: Campbell AJ,Spears GF,Borrie MJ

    更新日期:1990-01-01 00:00:00

  • Including papers in languages other than English in systematic reviews: important, feasible, yet often omitted.

    abstract::A truly international and systematic review (SR) identifies and synthesizes relevant evidence regardless of the geographical provenance or language of publication. Despite recommendations, international SRs continue to exclude papers in languages other than English (LOE) at searching, screening, and analysis phases ei...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2019.03.004

    authors: Walpole SC

    更新日期:2019-07-01 00:00:00

  • ROC area discrimination (ROCAD) curve: a new method of evaluating the discriminating ability of ordinal scales.

    abstract:OBJECTIVE:The area under the receiver operating characteristic (ROC) curve has been frequently used to assess the ability of diagnostic tests to discriminate between individuals with and without a disease. In this paper, we propose to use the ROC area to evaluate the discriminating power of ordinal measures, such as ma...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2007.11.016

    authors: Kopec JA,Sayre EC

    更新日期:2008-10-01 00:00:00

  • Methods for detecting, quantifying, and adjusting for dissemination bias in meta-analysis are described.

    abstract:OBJECTIVE:To systematically review methodological articles which focus on nonpublication of studies and to describe methods of detecting and/or quantifying and/or adjusting for dissemination in meta-analyses. To evaluate whether the methods have been applied to an empirical data set for which one can be reasonably conf...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审

    doi:10.1016/j.jclinepi.2016.04.015

    authors: Mueller KF,Meerpohl JJ,Briel M,Antes G,von Elm E,Lang B,Motschall E,Schwarzer G,Bassler D

    更新日期:2016-12-01 00:00:00

  • Selecting a patient characteristics index for the prediction of medical outcomes using administrative claims data.

    abstract::Recently, there has been a great deal of discussion regarding the use of administrative databases to study outcomes of medical care. A major issue in this discussion is how to classify patients in terms of characteristics such as disease-severity, comorbidities, resource needs, stability, etc. Different indices have b...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(94)00202-2

    authors: Melfi C,Holleman E,Arthur D,Katz B

    更新日期:1995-07-01 00:00:00

  • A stroke prediction score in the elderly: validation and Web-based application.

    abstract::The objective of this study was to construct a prediction model for predicting stroke in an elderly U.S. population, and to assess the accuracy in this population of other previously published prediction models. The subjects were participants in the Cardiovascular Health Study: 2,495 men and 3,393 women age 65 years a...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/s0895-4356(01)00434-6

    authors: Lumley T,Kronmal RA,Cushman M,Manolio TA,Goldstein S

    更新日期:2002-02-01 00:00:00

  • The Chinese version of the Tampa Scale for Kinesiophobia was cross-culturally adapted and validated in patients with low back pain.

    abstract:OBJECTIVES:The aim of the present study was to obtain a cross-cultural adaptation and evaluation of a Simplified Chinese (SC) version of the Tampa Scale for Kinesiophobia (TSK) for use in patients with low back pain (LBP). STUDY DESIGN AND SETTING:The TSK was translated and adapted cross-culturally following internati...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2015.07.003

    authors: Wei X,Xu X,Zhao Y,Hu W,Bai Y,Li M

    更新日期:2015-10-01 00:00:00

  • Quality of life and functional health of primary care patients.

    abstract::Quality of life and functional health were measured cross-sectionally for 314 adult ambulatory primary care patients in a rural clinic and found to be much better for patients with low severity of illness who required no confinement to home because of health problems, than for patients with high severity of illness wh...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(92)90171-i

    authors: Parkerson GR Jr,Broadhead WE,Tse CK

    更新日期:1992-11-01 00:00:00

  • Using the outcome for imputation of missing predictor values was preferred.

    abstract:BACKGROUND AND OBJECTIVE:Epidemiologic studies commonly estimate associations between predictors (risk factors) and outcome. Most software automatically exclude subjects with missing values. This commonly causes bias because missing values seldom occur completely at random (MCAR) but rather selectively based on other (...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2006.01.009

    authors: Moons KG,Donders RA,Stijnen T,Harrell FE Jr

    更新日期:2006-10-01 00:00:00

  • Using the STROBE statement: survey findings emphasized the role of journals in enforcing reporting guidelines.

    abstract:OBJECTIVES:The objective of the study was to identify factors affecting the use of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement, specifically authors' attitudes toward and experiences with it. STUDY DESIGN AND SETTING:An online survey was distributed to authors of observa...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2019.07.019

    authors: Sharp MK,Bertizzolo L,Rius R,Wager E,Gómez G,Hren D

    更新日期:2019-12-01 00:00:00

  • Psychometric evaluation supported construct validity, temporal stability, and responsiveness of the Osteoarthritis Questionnaire.

    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

    authors: Busija L,Osborne RH,Tatangelo G,Niutta S,Buchbinder R

    更新日期:2019-10-01 00:00:00

  • Comparison of the statistical efficiency of case-crossover and case-control designs: application to severe cutaneous adverse reactions.

    abstract::Although case-crossover analyses have lately emerged as an alternative to case-control analyses in epidemiological studies, it is not yet known in which situations they give reliable conclusions. In this work, the case-crossover and the case-control designs were first compared on the basis of a dataset from a publishe...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/s0895-4356(01)00404-8

    authors: Viboud C,Boëlle PY,Kelly J,Auquier A,Schlingmann J,Roujeau JC,Flahault A

    更新日期:2001-12-01 00:00:00

  • Effects on blood pressure of a decrease in sodium use in institutional food preparation: the Exeter-Andover Project.

    abstract::To judge the effect on blood pressure, sodium intake of students at two boarding high schools was reduced by 15-20% through changes in food purchasing and in preparation practices in the schools' kitchens. Students were not asked to change their usual eating habits. Each school served alternately as the control or int...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(89)90056-5

    authors: Ellison RC,Capper AL,Stephenson WP,Goldberg RJ,Hosmer DW Jr,Humphrey KF,Ockene JK,Gamble WJ,Witschi JC,Stare FJ

    更新日期:1989-01-01 00:00:00

  • GRADE guidelines: 10. Considering resource use and rating the quality of economic evidence.

    abstract:OBJECTIVES:In this article, we describe how to include considerations about resource utilization when making recommendations according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. STUDY DESIGN AND SETTINGS:We focus on challenges with rating the confidence in effect estima...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审

    doi:10.1016/j.jclinepi.2012.04.012

    authors: Brunetti M,Shemilt I,Pregno S,Vale L,Oxman AD,Lord J,Sisk J,Ruiz F,Hill S,Guyatt GH,Jaeschke R,Helfand M,Harbour R,Davoli M,Amato L,Liberati A,Schünemann HJ

    更新日期:2013-02-01 00:00:00

  • Characteristics of nonparticipants differed based on reason for nonparticipation: a study involving the chronically ill.

    abstract:BACKGROUND:Individuals who do and do not participate in studies often have different characteristics. The profile of nonparticipants may vary by type of nonparticipation. Few cross-sectional or longitudinal studies of chronically ill individuals identify these differences at baseline and of those that do; many do not h...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2007.11.002

    authors: Holden L,Ware RS,Passey M

    更新日期:2008-07-01 00:00:00

  • Risk factors for site specific extracranial carotid artery plaque distribution as measured by B-mode ultrasound.

    abstract::The effect of age, sex, diabetes, hypertension, pulse rate and cigarette smoking on extracranial carotid artery plaque thickness evaluated by B-mode ultrasonography was investigated in a cross-sectional study of 698 white men, 730 white women, 77 black men and 76 black women as part of a clinical ultrasound registry. ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(89)90151-0

    authors: Tell GS,Howard G,McKinney WM

    更新日期:1989-01-01 00:00:00