Covariate adjustment increased power in randomized controlled trials: an example in traumatic brain injury.

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 Significant Head Injury (CRASH) RCT of corticosteroid vs. placebo. Adjustment was made using logistic regression for baseline covariates of two validated risk models derived from external data (International Mission on Prognosis and Analysis of Clinical Trials in Traumatic Brain Injury [IMPACT]) and from the CRASH data. The relative sample size (RESS) measure, defined as the ratio of the sample size required by an adjusted analysis to attain the same power as the unadjusted reference analysis, was used to assess the impact of adjustment. RESULTS:Corticosteroid was associated with higher mortality compared with placebo (odds ratio=1.25, 95% confidence interval=1.13-1.39). RESS of 0.79 and 0.73 were obtained by adjustment using the IMPACT and CRASH models, respectively, which, for example, implies an increase from 80% to 88% and 91% power, respectively. CONCLUSION:Moderate gains in power may be obtained using covariate adjustment from logistic regression in heterogeneous conditions such as TBI. Although analyses of RCTs might consider covariate adjustment to improve power, we caution against this approach in the planning of RCTs.

journal_name

J Clin Epidemiol

authors

Turner EL,Perel P,Clayton T,Edwards P,Hernández AV,Roberts I,Shakur H,Steyerberg EW,CRASH trial collaborators.

doi

10.1016/j.jclinepi.2011.08.012

subject

Has Abstract

pub_date

2012-05-01 00:00:00

pages

474-81

issue

5

eissn

0895-4356

issn

1878-5921

pii

S0895-4356(11)00277-0

journal_volume

65

pub_type

杂志文章,随机对照试验
  • Reducing population stratification bias: stratum matching is better than exposure.

    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

    authors: Lee WC,Wang LY

    更新日期:2009-01-01 00:00:00

  • Cohort study of ethnic group and cardiovascular and total mortality over 15 years.

    abstract::Altogether, 3365 men and 3266 women who attended two cardiovascular screenings in 1974-1975 and 1977-1978, have been followed with respect to death for an average of 15 years. The mortality from coronary heart disease was lower in men who reported being of Lappish origin than in men who reported Norse origin at both s...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/s0895-4356(97)00021-8

    authors: Tverdal A

    更新日期:1997-06-01 00:00:00

  • False discovery rate control is a recommended alternative to Bonferroni-type adjustments in health studies.

    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

    authors: Glickman ME,Rao SR,Schultz MR

    更新日期:2014-08-01 00:00:00

  • Influence of gender in acute and long-term cardiac mortality after a first myocardial infarction. REGICOR Investigators.

    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

    authors: Marrugat J,Antó JM,Sala J,Masiá R

    更新日期:1994-02-01 00:00:00

  • The epidemiology of mass breast cancer screening--a plea for a valid measure of benefit.

    abstract::The present paper analyses the epidemiologic effects of mass breast cancer screening. Mass mammography may possibly achieve a breast cancer mortality reduction in relative risk terms. However, this does not necessarily represent a net benefit. It is argued that the benefits and adverse effects of a screening programme...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审

    doi:10.1016/0895-4356(90)90002-7

    authors: Schmidt JG

    更新日期:1990-01-01 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

  • An approach to measuring quality of midwifery care.

    abstract::In perinatology "Outcome" is almost always defined in terms of mortality or serious morbidity. Evaluation of care for normal pregnancy and midwifery care in particular cannot rely only on outcome measures per se, but must also take the means and interventions by which these are achieved into account. Perinatal Backgro...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(95)00549-8

    authors: Wiegers TA,Keirse MJ,Berghs GA,van der Zee J

    更新日期:1996-03-01 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

  • Multivariate graphical methods provide an insightful way to formulate explanatory hypotheses from limited categorical data.

    abstract:OBJECTIVE:Graphical methods for generating explanatory hypotheses from limited categorical data are described and illustrated. STUDY DESIGN AND SETTING:Univariate, bivariate, multivariate, and multiplicative graphical methods were applied to clinical data regarding very ill older persons. The data to which these metho...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2011.06.007

    authors: Van Ness PH,Murphy TE,Araujo KL,Pisani MA

    更新日期:2012-02-01 00:00:00

  • Fracture risk following bilateral oophorectomy.

    abstract::To assess fracture risk following bilateral oophorectomy, we conducted a population-based retrospective cohort study among the 463 Rochester, Minnesota women who underwent bilateral oophorectomy for benign ovarian conditions in 1950-1979. During 7220 person-years of observation, there appeared to be a modest increase ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(96)00211-9

    authors: Melton LJ 3rd,Crowson CS,Malkasian GD,O'Fallon WM

    更新日期:1996-10-01 00:00:00

  • Relationships of site of infarction and history of previous infarction with short- and long-term prognosis after acute myocardial infarction in Japan.

    abstract::We studied the outcome in 308 patients with acute myocardial infarction (MI) admitted to the coronary care unit of Kobe General Hospital. Short-term outcome (within 28 days after MI) and long-term outcome (more than 28 days) were examined with survival curves to find any relationship with a history of previous MI and ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(92)90186-q

    authors: Nishi N,Nakanishi N,Kuroda K,Koizumi K,Yoshikawa J,Tatara K

    更新日期:1992-01-01 00:00:00

  • Do medical devices have enhanced placebo effects?

    abstract::Although the placebo in a clinical trial is often considered simply a baseline against which to evaluate the efficacy of a clinical intervention, there is evidence that the magnitude of placebo effect may be a critical factor in determining the results of a trial. This article examines the question of whether devices ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审

    doi:10.1016/s0895-4356(00)00206-7

    authors: Kaptchuk TJ,Goldman P,Stone DA,Stason WB

    更新日期:2000-08-01 00:00:00

  • Female specialists were more likely to respond to a postal questionnaire about drug treatments for Alzheimer disease.

    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

    authors: Oremus M,Wolfson C

    更新日期:2004-06-01 00:00:00

  • Frequent inappropriate use of unweighted summary statistics in systematic reviews of pathogen genotypes or genogroups.

    abstract:OBJECTIVES:Our study aimed to systematically assess and report the methodological quality used in epidemiological systematic reviews (SRs) and meta-analysis (MA) of pathogen genotypes/genogroups. STUDY DESIGN AND SETTING:Nine electronic databases and manual search of reference lists were used to identify relevant stud...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审

    doi:10.1016/j.jclinepi.2019.11.009

    authors: Tran L,Nhu Y M,Le Ba Nghia T,Hendam A,Vuong NL,Alzalal E,Sayed AM,Hussain MM,Sharma A,Tieu T,Mathenge PG,Hirayama K,Alexander N,Huy NT

    更新日期:2020-03-01 00:00:00

  • GRADE guidelines 27: how to calculate absolute effects for time-to-event outcomes in summary of findings tables and Evidence Profiles.

    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

    authors: Skoetz N,Goldkuhle M,van Dalen EC,Akl EA,Trivella M,Mustafa RA,Nowak A,Dahm P,Schünemann H,Bender R,GRADE Working Group.

    更新日期:2020-02-01 00:00:00

  • Simultaneous interval estimates of the odds ratio in studies with two or more comparisons.

    abstract::More than one odds ratio estimate will often arise from a single epidemiologic study. Examples of designs where this may occur include those where there is more than one case or control group, and investigations of several risk factors as part of the same study. Various methods for presenting multiple interval estimat...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(89)90132-7

    authors: Holford TR,Walter SD,Dunnett CW

    更新日期:1989-01-01 00:00:00

  • Measuring health status: what are the necessary measurement properties?

    abstract::The different measurement properties necessary for instruments whose goal is to detect differences between subjects at a single point in time (discriminative instruments) and those whose goal is to detect longitudinal change within subjects (evaluative instruments) is becoming increasingly recognized. Up to now, requi...

    journal_title:Journal of clinical epidemiology

    pub_type: 评论,杂志文章

    doi:10.1016/0895-4356(92)90194-r

    authors: Guyatt GH,Kirshner B,Jaeschke R

    更新日期:1992-12-01 00:00:00

  • Deficiencies in addressing effect modification in network meta-analyses: a meta-epidemiological survey.

    abstract:OBJECTIVE:The objectives of this study were to evaluate the current state of reporting and handling of effect modification in network meta-analyses (NMAs) and perform exploratory analyses to identify variables that are potentially associated with incomplete reporting of effect modifiers in NMAs. STUDY DESIGN AND SETTI...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,meta分析

    doi:10.1016/j.jclinepi.2017.06.004

    authors: Kovic B,Zoratti MJ,Michalopoulos S,Silvestre C,Thorlund K,Thabane L

    更新日期:2017-08-01 00:00:00

  • The occurrence of Simpson's paradox if site-level effect was ignored in the TREAT Asia HIV Observational Database.

    abstract:OBJECTIVES:In multisite human immunodeficiency virus (HIV) observational cohorts, clustering of observations often occurs within sites. Ignoring clustering may lead to "Simpson's paradox" (SP) where the trend observed in the aggregated data is reversed when the groups are separated. This study aimed to investigate the ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.jclinepi.2016.01.030

    authors: Jiamsakul A,Kerr SJ,Chandrasekaran E,Huelgas A,Taecharoenkul S,Teeraananchai S,Wan G,Ly PS,Kiertiburanakul S,Law M,TREAT Asia HIV Observational Database (TAHOD).

    更新日期:2016-08-01 00:00:00

  • Sample size considerations for studies comparing survival curves using historical controls.

    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

    authors: Dixon DO,Simon R

    更新日期:1988-01-01 00:00:00

  • A likelihood-based approach to P-value interpretation provided a novel, plausible, and clinically useful research study metric.

    abstract:OBJECTIVES:Interpretation of clinical research findings using the paradigm of null hypothesis significance testing has a number of limitations. These include arbitrary dichotomization of results, lack of incorporation of study power and prior probability, and the confusing use of conditional probability. This study aim...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2017.08.016

    authors: Adams NG,O'Reilly G

    更新日期:2017-12-01 00:00:00

  • The Kaiser Permanente inpatient risk adjustment methodology was valid in an external patient population.

    abstract:OBJECTIVES:Accurately predicting hospital mortality is necessary to measure and compare patient care. External validation of predictive models is required to truly prove their utility. This study assessed the Kaiser Permanente inpatient risk adjustment methodology for hospital mortality in a patient population distinct...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.jclinepi.2009.08.020

    authors: van Walraven C,Escobar GJ,Greene JD,Forster AJ

    更新日期:2010-07-01 00:00:00

  • Use of global assessment measures in dementia drug trials.

    abstract::I argue in this paper that the use of a global clinical impression of change as a primary measure in dementia drug trials is appropriate, given that we do not yet understand clearly enough what Alzheimer's disease looks like as it gets better. ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(94)90039-6

    authors: Rockwood K

    更新日期:1994-01-01 00:00:00

  • Predictors of attrition in a longitudinal cognitive aging study: the Maastricht Aging Study (MAAS).

    abstract::A large sample of older participants of the Maastricht Aging Study (MAAS) were compared to drop-outs at the 3-year follow-up with respect to socio-demographic, health, and cognitive characteristics. In addition, the impact of selective drop-out on measures of cognitive change was examined. To this end, hypothetical sc...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/s0895-4356(01)00473-5

    authors: Van Beijsterveldt CE,van Boxtel MP,Bosma H,Houx PJ,Buntinx F,Jolles J

    更新日期:2002-03-01 00:00:00

  • Recall bias in case-control studies: an empirical analysis and theoretical framework.

    abstract::Previous work has suggested that recall bias in case-control studies may be more serious when the overall study quality is lower. This paper summarizes a systematic literature search to examine the question. All relevant studies published between 1966 and 1990 were included if they met the following criteria: (1) they...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/0895-4356(94)00132-a

    authors: Chouinard E,Walter S

    更新日期:1995-02-01 00:00:00

  • A changing relationship between disability and survival in the elderly population: differences by age.

    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

    authors: Lamarca R,Ferrer M,Andersen PK,Liestol K,Keiding N,Alonso J

    更新日期:2003-12-01 00:00:00

  • Procedures that assess inconsistency in meta-analyses can assess the likelihood of response bias in multiwave surveys.

    abstract:BACKGROUND AND OBJECTIVE:Response bias may affect the result of surveys with <100% response rate. We applied methods commonly used in meta-analysis to ascertain the extent to which response bias affects multiwave survey results. METHODS:To test hypotheses of between-wave similarity, we used the Cochran-Armitage test f...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2004.11.027

    authors: Montori VM,Leung TW,Walter SD,Guyatt GH

    更新日期:2005-08-01 00:00:00

  • Multivariable adjustments counteract spectrum and test review bias in accuracy studies.

    abstract:OBJECTIVES:The STAndards for Reporting studies of Diagnostic accuracy (STARD) for investigators and editors and the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) for reviewers and readers offer guidelines for the quality and reporting of test accuracy studies. These guidelines address and propose some solu...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2008.02.007

    authors: Bachmann LM,ter Riet G,Weber WE,Kessels AG

    更新日期:2009-04-01 00:00:00

  • P value-driven methods were underpowered to detect publication bias: analysis of Cochrane review meta-analyses.

    abstract:OBJECTIVES:The aim of the study was to investigate the effect of number of studies in a meta-analysis on the detection of publication bias using P value-driven methods. METHODS:The proportion of meta-analyses detected by Egger's, Harbord's, Peters', and Begg's tests to have asymmetry suggestive of publication bias wer...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章

    doi:10.1016/j.jclinepi.2019.11.011

    authors: Furuya-Kanamori L,Xu C,Lin L,Doan T,Chu H,Thalib L,Doi SAR

    更新日期:2020-02-01 00:00:00

  • Does physical activity lower blood pressure: a critical review of the clinical trials.

    abstract::This review critically appraises 22 recent articles of trials of physical activity, as a means of reducing blood pressure. The quality of the literature remains poor and of the 13 controlled trials of habitual activity only one did not have a major design fault. Overall, blood pressure was reduced by physical activity...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审

    doi:10.1016/0895-4356(92)90093-3

    authors: Arroll B,Beaglehole R

    更新日期:1992-05-01 00:00:00