当前位置： SCI文献检索 > JOURNAL OF CLINICAL EPIDEMIOLOGY期刊下所有文献 > Choice of treatment-effect measures when noninferiority margins originally defined in absolute difference translated into relative difference influenced the results of clinical trials.

Choice of treatment-effect measures when noninferiority margins originally defined in absolute difference translated into relative difference influenced the results of clinical trials.

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. Different hypotheses may explain such discordant results including a mistaken hypothesized distribution of time to failure and an overestimation of failure rates in the protocol. In a simulation study, we investigate different situations in comparing analyses based hazard ratio (HR), risk difference estimated by Kaplan-Meier curves, and difference in restricted mean survival time. We also compared these three analyses on genuine data from a recent equivalence trial. RESULTS:In the equivalence trial, two analyses would have concluded equivalence, whereas the original analysis based on HR estimate did not declare equivalence. Results of our simulation study indicate little to moderate differences between the three analyses when the true distribution of time to failure is different to the hypothesized distribution. The main discordant results are found when failure rates have been overestimated or underestimated regardless of the distribution. CONCLUSION:With the distributions investigated, differences between analyses based on different measures are much more driven by mistaken hypothesized failure rates than by the shape of the distribution of time to failure.

journal_name

J Clin Epidemiol

journal_title

Journal of clinical epidemiology

authors

Abulizi X,Flandre P

doi

10.1016/j.jclinepi.2017.12.010

subject

Has Abstract

pub_date

2018-04-01 00:00:00

pages

63-72

eissn

0895-4356

issn

1878-5921

pii

S0895-4356(17)31007-7

journal_volume

96

pub_type

杂志文章

相关文献

JOURNAL OF CLINICAL EPIDEMIOLOGY文献大全
  • Serum albumin and risk of stroke, coronary heart disease, and mortality: the role of cigarette smoking.

    abstract：OBJECTIVE:Lower levels of serum albumin are associated with increased risk of all-cause and cardiovascular mortality as well as with coronary heart disease and stroke incidence. These relationships have been examined with specific focus on the role of cigarette smoking. STUDY DESIGN AND SETTING:A prospective study of ...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/j.jclinepi.2003.07.001

    authors： Shaper AG,Wannamethee SG,Whincup PH

    更新日期：2004-02-01 00:00:00

  • Using postal randomization to replace telephone randomization had no significant effect on recruitment of patients.

    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

    authors： Brealey SD,Atwell C,Bryan S,Coulton S,Cox H,Cross B,Fylan F,Garratt A,Gilbert FJ,Gillan MG,Hendry M,Hood K,Houston H,King D,Morton V,Orchard J,Robling M,Russell IT,Torgerson D,Wadsworth V,Wilkinson C

    更新日期：2007-10-01 00:00:00

  • Small improvement in the area under the receiver operating characteristic curve indicated small changes in predicted risks.

    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

    authors： Martens FK,Tonk EC,Kers JG,Janssens AC

    更新日期：2016-11-01 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

  • A systematic review identified few methods and strategies describing when and how to update systematic reviews.

    abstract：OBJECTIVE:Systematic reviews (SRs) are convenient summaries of evidence for health care practitioners. They form a basis for clinical practice guidelines and suggest directions for new research. SRs are most helpful if they are current; however, most of them are not being updated. This SR summarizes strategies and meth...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章,评审

    doi：10.1016/j.jclinepi.2007.03.008

    authors： Moher D,Tsertsvadze A,Tricco AC,Eccles M,Grimshaw J,Sampson M,Barrowman N

    更新日期：2007-11-01 00:00:00

  • Mortality in a population with long-term exposure to inorganic selenium via drinking water.

    abstract：:We analyzed the 1986-1997 mortality in a cohort of 2065 residents of an Italian municipality which had been exposed to drinking water with a high content of inorganic selenium over a long period of time, and compared it with mortality in the remainder of the municipal population. Mortality from malignant neoplasms inc...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/s0895-4356(00)00233-x

    authors： Vinceti M,Nacci G,Rocchi E,Cassinadri T,Vivoli R,Marchesi C,Bergomi M

    更新日期：2000-10-01 00:00:00

  • Colorectal cancer deaths as determined by expert committee and from death certificate: a comparison. The Minnesota Study.

    abstract：:For deaths during the first 13 years of follow-up of the Minnesota Colon Cancer Control Study, an expert committee using numerous medical documents, and a nosologist using only the death certificate independently determined whether colorectal cancer caused the death and, if not, whether the disease was present at deat...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/s0895-4356(99)00016-5

    authors： Ederer F,Geisser MS,Mongin SJ,Church TR,Mandel JS

    更新日期：1999-05-01 00:00:00

  • Dyspepsia: how should we measure it?

    abstract：:This study developed and validated a multidimensional measure of dyspepsia. A questionnaire was administered to 126 patients with dyspepsia who presented for care at a VA outpatient clinic and a family physician's private office. Dyspepsia-specific health was measured by self-report using: (1) an existing dyspepsia sc...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/s0895-4356(97)00245-x

    authors： Kuykendall DH,Rabeneck L,Campbell CJ,Wray NP

    更新日期：1998-02-01 00:00:00

  • A case-control evaluation of treatment efficacy: the example of magnesium sulfate prophylaxis against eclampsia in patients with preeclampsia.

    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

    authors： Abi-Said D,Annegers JF,Combs-Cantrell D,Suki R,Frankowski RF,Willmore LJ

    更新日期：1997-04-01 00:00:00

  • Translation and psychometric evaluation of a Chinese version of the SF-36 Health Survey in the United States.

    abstract：:Outcome measures are rapidly becoming standard tools in the assessment of clinical effectiveness and in the measurement of health status in populations. In this article we document the development of a self-administered Chinese version of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and report t...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/s0895-4356(98)00104-8

    authors： Ren XS,Amick B 3rd,Zhou L,Gandek B

    更新日期：1998-11-01 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

  • A 67-item stress resilience item bank showing high content validity was developed in a psychosomatic sample.

    abstract：OBJECTIVES:To develop the first item bank to measure stress resilience (SR) in clinical populations. STUDY DESIGN AND SETTING:Qualitative item development resulted in an initial pool of 131 items covering a broad theoretical SR concept. These items were tested in n = 521 patients at a psychosomatic outpatient clinic. ...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/j.jclinepi.2018.04.004

    authors： Obbarius N,Fischer F,Obbarius A,Nolte S,Liegl G,Rose M

    更新日期：2018-08-01 00:00:00

  • Estimation of test error rates, disease prevalence and relative risk from misclassified data: a review.

    abstract：:We review methods for the analysis of categorical clinical and epidemiological data, in which the observations are subject to misclassification. Under certain conditions, it is possible to estimate error parameters such as sensitivity, specificity, relative risk, or predictive value, even though no definitive classifi...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章,评审

    doi：10.1016/0895-4356(88)90110-2

    authors： Walter SD,Irwig LM

    更新日期：1988-01-01 00:00:00

  • Linguistic validation and reliability properties are weak investigated of most dementia-specific quality of life measurements-a systematic review.

    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

    authors： Dichter MN,Schwab CG,Meyer G,Bartholomeyczik S,Halek M

    更新日期：2016-02-01 00:00:00

  • Clinical replicability of rehabilitation interventions in randomized controlled trials reported in main journals is inadequate.

    abstract：OBJECTIVE:The objective of this study was to study if randomized controlled trials (RCTs) in rehabilitation (a field where complex interventions prevail) published in main journals include all the details needed to replicate the intervention in clinical practice (clinical replicability). STUDY DESIGN AND SETTING:Forty...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/j.jclinepi.2019.06.008

    authors： Negrini S,Arienti C,Pollet J,Engkasan JP,Francisco GE,Frontera WR,Galeri S,Gworys K,Kujawa J,Mazlan M,Rathore FA,Schillebeeckx F,Kiekens C,REREP study participants.

    更新日期：2019-10-01 00:00:00

  • Cherry-picking by trialists and meta-analysts can drive conclusions about intervention efficacy.

    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., jour...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章,评审

    doi：10.1016/j.jclinepi.2017.07.014

    authors： 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,Dicke

    更新日期：2017-11-01 00:00:00

  • Identifying studies for systematic reviews of diagnostic tests was difficult due to the poor sensitivity and precision of methodologic filters and the lack of information in the abstract.

    abstract：BACKGROUND AND OBJECTIVES:Methods to identify studies for systematic reviews of diagnostic accuracy are less well developed than for reviews of intervention studies. This study assessed (1) the sensitivity and precision of five published search strategies and (2) the reliability and accuracy of reviewers screening the ...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/j.jclinepi.2004.09.011

    authors： Doust JA,Pietrzak E,Sanders S,Glasziou PP

    更新日期：2005-05-01 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

  • Adherence measurement and patient recruitment methods are poor in intervention trials to improve patient adherence.

    abstract：OBJECTIVES:To develop a scale and survey the measurement of patient adherence and patient recruitment, and to explore how these methods impact the results in randomized controlled trials of interventions to improve patient adherence to medications. STUDY DESIGN:Analytic survey of a purposively selected sample of patie...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章,评审

    doi：10.1016/j.jclinepi.2014.06.008

    authors： Jeffery RA,Navarro T,Wilczynski NL,Iserman EC,Keepanasseril A,Sivaramalingam B,Agoritsas T,Haynes RB

    更新日期：2014-10-01 00:00:00

  • Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses.

    abstract：OBJECTIVES:To evaluate meta-analyses with trial sequential analysis (TSA). TSA adjusts for random error risk and provides the required number of participants (information size) in a meta-analysis. Meta-analyses not reaching information size are analyzed with trial sequential monitoring boundaries analogous to interim m...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/j.jclinepi.2007.10.007

    authors： Brok J,Thorlund K,Gluud C,Wetterslev J

    更新日期：2008-08-01 00:00:00

  • Parents were accurate proxy reporters of urgent pediatric asthma health services: a retrospective agreement analysis.

    abstract：OBJECTIVE:To assess agreement between parents' proxy reports of children's respiratory-related health service use and administrative data. STUDY DESIGN AND SETTING:A retrospective analysis of statistical agreement between clinical and claims data for reports of physician visits, emergency department (ED) visits, and h...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/j.jclinepi.2007.02.002

    authors： Ungar WJ,Davidson-Grimwood SR,Cousins M

    更新日期：2007-11-01 00:00:00

  • An embedded mixed-methods study highlighted a lack of discussions on retention in clinical trial consultations.

    abstract：OBJECTIVES:This study investigated trial consultations to identify whether and to what extent discussions of retention are present. STUDY DESIGN AND SETTING:This embedded mixed-methods study design included a purposive sample of audio-recorded trial consultations obtained from four sites of a large multicenter UK-base...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/j.jclinepi.2020.03.011

    authors： Tunji-Ajayi P,Duncan EM,Gillies K

    更新日期：2020-07-01 00:00:00

  • A systematic review finds prediction models for chronic kidney disease were poorly reported and often developed using inappropriate methods.

    abstract：BACKGROUND:Chronic kidney disease (CKD) is a global health concern that is increasing mainly as the result of increasing incidences of diabetes and hypertension. Furthermore, if left untreated, individuals with CKD may progress to end-stage kidney failure. Identifying individuals with undiagnosed CKD or those who are a...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章,评审

    doi：10.1016/j.jclinepi.2012.06.020

    authors： Collins GS,Omar O,Shanyinde M,Yu LM

    更新日期：2013-03-01 00:00:00

  • Structured decision-making drives guidelines panels' recommendations "for" but not "against" health interventions.

    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

    authors： Djulbegovic B,Reljic T,Elqayam S,Cuker A,Hozo I,Zhou Q,Li SA,Alexander P,Nieuwlaat R,Wiercioch W,Schünemann H,Guyatt G

    更新日期：2019-06-01 00:00:00

  • Diagnostic interpretation of electrocardiograms in population-based research: computer program research physicians, or cardiologists?

    abstract：:We assessed the performance of diagnostic electrocardiogram (ECG) interpretation by the computer program MEANS and by research physicians, compared to cardiologists, in a physician-based study. To establish a strategy for ECG interpretation in health surveys, we also studied the diagnostic capacity of three scenarios:...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/s0895-4356(97)00100-5

    authors： de Bruyne MC,Kors JA,Hoes AW,Kruijssen DA,Deckers JW,Grosfeld M,van Herpen G,Grobbee DE,van Bemmel JH

    更新日期：1997-08-01 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

  • 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

  • An enhancement of ROC curves made them clinically relevant for diagnostic-test comparison and optimal-threshold determination.

    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

    authors： Subtil F,Rabilloud M

    更新日期：2015-07-01 00:00:00

  • Beyond Mendelian randomization: how to interpret evidence of shared genetic predictors.

    abstract：OBJECTIVE:Mendelian randomization is a popular technique for assessing and estimating the causal effects of risk factors. If genetic variants which are instrumental variables for a risk factor are shown to be additionally associated with a disease outcome, then the risk factor is a cause of the disease. However, in man...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/j.jclinepi.2015.08.001

    authors： Burgess S,Butterworth AS,Thompson JR

    更新日期：2016-01-01 00:00:00

  • A prospective study of factors affecting age at menopause.

    abstract：:This paper describes a multivariate analysis of a 3-year prospective study of the covariates of age at menopause among women who were randomly sampled from a general population. This approach avoids three problems that may account for the inconsistent results of prior studies: recall bias in retrospectively collected ...

    journal_title：Journal of clinical epidemiology

    pub_type： 杂志文章

    doi：10.1016/0895-4356(89)90044-9

    authors： Brambilla DJ,McKinlay SM

    更新日期：1989-01-01 00:00:00