Various randomized designs can be used to evaluate medical tests.


OBJECTIVE:To explore designs for evaluating the prognostic and predictive value of medical tests and their effect on patient outcome. STUDY DESIGN:Theoretical analysis with examples from the medical literature. RESULTS:For evaluating the prognostic value of a test, one can include the test at baseline in prognostic studies. To evaluate the value of test in predicting treatment outcome, the test results can be used as baseline information in randomized controlled trials of treatment. To compare the prognostic or predictive value of two or more tests, the test result combinations can be used as baseline information. To evaluate the effect on patient outcome, randomized controlled trials of test strategies are an option. Randomization can apply to all tested or be restricted to specific subgroups, such as those with discordant test results, to increase the efficiency of trials. CONCLUSION:The prognostic and predictive value of medical tests can and should be evaluated, to demonstrate the test's ability to guide clinical decision making and to improve patient outcome. Various randomized designs can be used to evaluate the effects on testing on patient outcome.


J Clin Epidemiol


Lijmer JG,Bossuyt PM




Has Abstract


2009-04-01 00:00:00














  • Meta-analysis identifies Back Pain Questionnaire reliability influenced more by instrument than study design or population.

    abstract:OBJECTIVE:To assess if predefined variables in study design, instrument type, and patient characteristics account for variance in reported retest reliability for the Oswestry Disability Index (ODI) and Roland-Morris Questionnaire (RMQ). A second aim was a more precise estimate of instrument reliability. STUDY DESIGN A...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,meta分析,评审


    authors: Geere JH,Geere JA,Hunter PR

    更新日期:2013-03-01 00:00:00

  • Testing multiple statistical hypotheses resulted in spurious associations: a study of astrological signs and health.

    abstract:OBJECTIVES:To illustrate how multiple hypotheses testing can produce associations with no clinical plausibility. STUDY DESIGN AND SETTING:We conducted a study of all 10,674,945 residents of Ontario aged between 18 and 100 years in 2000. Residents were randomly assigned to equally sized derivation and validation cohort...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Austin PC,Mamdani MM,Juurlink DN,Hux JE

    更新日期:2006-09-01 00:00:00

  • The effect of exposure variance and exposure measurement error on study sample size: implications for the design of epidemiologic studies.

    abstract::A small variability of exposure in a population, for example small variance in nutrient intake, limits the power of an epidemiologic study. McKeown-Eyssen and Thomas (J Chron Dis 1985; 38:559-568) have shown that by selecting a population with larger exposure variance vs one with smaller variance, the study sample siz...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审


    authors: White E,Kushi LH,Pepe MS

    更新日期:1994-08-01 00:00:00

  • Methodologic considerations in measuring glycosylated hemoglobin in epidemiologic studies.

    abstract::Multiple linear regression was used to predict an incubated glycosylated hemoglobin value from the unincubated value and blood glucose. Hemoglobin A1 (HbA1) was measured by a disposable microcolumn technique in a large, geographically defined population of diabetic persons in southern Wisconsin. During the study, incu...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Moss SE,Klein R,Klein BE,Spennetta TL,Shrago ES

    更新日期:1988-01-01 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


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

    更新日期:2019-10-01 00:00:00

  • Developing a stroke severity index based on administrative data was feasible using data mining techniques.

    abstract:OBJECTIVES:Case-mix adjustment is difficult for stroke outcome studies using administrative data. However, relevant prescription, laboratory, procedure, and service claims might be surrogates for stroke severity. This study proposes a method for developing a stroke severity index (SSI) by using administrative data. ST...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Sung SF,Hsieh CY,Kao Yang YH,Lin HJ,Chen CH,Chen YW,Hu YH

    更新日期:2015-11-01 00:00:00

  • Optimal sampling in derivation studies was associated with improved discrimination in external validation for heart failure prognostic models.

    abstract:OBJECTIVES:The objective of the study was to identify determinants of external validity of prognostic models. STUDY DESIGN AND SETTING:We systematically searched for studies reporting prognostic models of heart failure (HF) and examined their performance for predicting 30-day death in a cohort of consecutive 3,452 acu...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Iwakami N,Nagai T,Furukawa TA,Tajika A,Onishi A,Nishimura K,Ogata S,Nakai M,Takegami M,Nakano H,Kawasaki Y,Alba AC,Guyatt GH,Shiraishi Y,Kohsaka S,Kohno T,Goda A,Mizuno A,Yoshikawa T,Anzai T,investigators for the

    更新日期:2020-05-01 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


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

    更新日期:1998-02-01 00:00:00

  • Measuring drug exposure: concordance between defined daily dose and days' supply depended on drug class.

    abstract:OBJECTIVES:To determine the concordance between two methods to measure drug exposure duration from pharmacy claim data. STUDY DESIGN AND SETTING:We conducted a cohort study using 2002-2007 US Medicaid data. Initiators of eight drug groups were identified: statins, metformin, atypical antipsychotics, warfarin, proton p...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Sinnott SJ,Polinski JM,Byrne S,Gagne JJ

    更新日期:2016-01-01 00:00:00

  • Measuring the impact of trauma care on survival: rates of preventable death, effectiveness, and efficacy.

    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


    authors: Salmi LR,Williams JI,Waxweiler RJ

    更新日期:1990-01-01 00:00:00

  • Present-at-admission diagnoses improved mortality risk adjustment among acute myocardial infarction patients.

    abstract:OBJECTIVE:Hospital mortality outcomes for acute myocardial infarction (AMI) patients are a focus of quality improvement programs conducted by government agencies. AMI mortality risk-adjustment models using administrative data typically adjust for baseline differences in mortality risk with a limited set of common and d...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Stukenborg GJ,Wagner DP,Harrell FE Jr,Oliver MN,Heim SW,Price AL,Han CK,Wolf AM,Connors AF Jr

    更新日期:2007-02-01 00:00:00

  • Finding bile duct injuries using record linkage: a validated study of complications following cholecystectomy.

    abstract::Laparoscopic cholecystectomy was introduced to Western Australia in 1991 and has become the method of choice for this procedure, although there are concerns about complications, particularly bile duct injuries. Previous studies have investigated this problem but have not confirmed the accuracy of coded information. We...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,多中心研究


    authors: Valinsky LJ,Hockey RL,Hobbs MS,Fletcher DR,Pikora TJ,Parsons RW,Tan P

    更新日期:1999-09-01 00:00:00

  • Both clinical epidemiology and population health perspectives can define the role of health care in reducing health disparities.

    abstract:OBJECTIVE:To compare and contrast clinical epidemiology and population health perspectives on the role of health care in reducing socioeconomic disparities in health. STUDY DESIGN AND SETTING:A review of concepts outlined in selected articles on population health and clinical epidemiology and a systematic literature s...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审


    authors: Anderson GM,Bronskill SE,Mustard CA,Culyer A,Alter DA,Manuel DG

    更新日期:2005-08-01 00:00:00

  • Minimal important change (MIC) based on a predictive modeling approach was more precise than MIC based on ROC analysis.

    abstract:OBJECTIVES:To present a new method to estimate a "minimal important change" (MIC) of health-related quality of life (HRQOL) scales, based on predictive modeling, and to compare its performance with the MIC based on receiver operating characteristic (ROC) analysis. To illustrate how the new method deals with variables t...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Terluin B,Eekhout I,Terwee CB,de Vet HC

    更新日期:2015-12-01 00:00:00

  • Conflict of interest as ethical shorthand: understanding the range and nature of "non-financial conflict of interest" in biomedicine.

    abstract:OBJECTIVES:The aim of the study was to identify the range of issues labeled as "non-financial conflicts of interest" in biomedicine, articulate the associated concerns, and analyze the implications of defining these issues as conflicts of interest. STUDY DESIGN AND SETTING:This was a qualitative study, triangulating d...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Grundy Q,Mayes C,Holloway K,Mazzarello S,Thombs BD,Bero L

    更新日期:2020-04-01 00:00:00

  • Relationships between change in aerobic fitness and changes in blood pressure and plasma lipids in men and women: the "Adelaide 1000" 4-year follow up.

    abstract::The aim was to assess relationships between increased aerobic fitness sustained over 4 years, and changes in blood pressure (SBP and DBP) and lipids. Measurements were made of BP, lipids, weight, and fitness in 1000 middle-aged men and women entering a fitness programme, and were repeated 2 and 4 years later. The 342 ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Sedgwick AW,Thomas DW,Davies M

    更新日期:1993-02-01 00:00:00

  • The diagnostic value of the measurement of the ankle-brachial systolic pressure index in primary health care.

    abstract::We investigated the value of the ankle-brachial systolic pressure index (ABPI) as a test for the diagnosis of peripheral arterial occlusive disease (PAOD) in general practice. ABPI measurements on 231 legs of 117 subjects performed in three general practice centers (GPC) were compared with the diagnostic conclusions o...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,多中心研究


    authors: Stoffers HE,Kester AD,Kaiser V,Rinkens PE,Kitslaar PJ,Knottnerus JA

    更新日期:1996-12-01 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


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

    更新日期:2017-08-01 00:00:00

  • Good agreement between parental and self-completed questionnaires about allergic diseases and environmental factors in teenagers.

    abstract:OBJECTIVES:To study whether the methodological change from parent to index subject as questionnaire respondent affected the prevalence estimates and risk factor patterns for allergic diseases in a longitudinal study. STUDY DESIGN AND SETTING:A prospective study of asthma and allergic diseases among children was begun ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Hedman L,Bjerg A,Perzanowski M,Rönmark E

    更新日期:2010-07-01 00:00:00

  • Assessment of functional status, low back disability, and use of diagnostic imaging in patients with low back pain and radiating leg pain.

    abstract::We analyzed data from outpatients with chronic low back pain (LBP) in the Veterans Health Study (n = 563) to examine the relationship between localized LBP intensity and radiating leg pain in assessing patient functional status, low back disability, and use of diagnostic imaging. Based on the localized LBP intensity, ...

    journal_title:Journal of clinical epidemiology

    pub_type: 临床试验,杂志文章,多中心研究


    authors: Ren XS,Selim AJ,Fincke G,Deyo RA,Linzer M,Lee A,Kazis L

    更新日期:1999-11-01 00:00:00

  • Methodological review showed correct absolute effect size estimates for time-to-event outcomes in less than one-third of cancer-related systematic reviews.

    abstract:OBJECTIVES:To evaluate in how many cancer-related Cochrane reviews hazard ratio (HR)-based absolute effects in summary of findings (SoF) tables have been correctly calculated and reported. STUDY DESIGN AND SETTING:We identified all Cochrane cancer intervention reviews that reported an HR for at least one outcome and p...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审


    authors: Skoetz N,Goldkuhle M,Weigl A,Dwan K,Labonté V,Dahm P,Meerpohl JJ,Djulbegovic B,van Dalen EC

    更新日期:2019-04-01 00:00:00

  • Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting.

    abstract:OBJECTIVES:The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. STUDY ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审


    authors: Zhang S,Liang F,Li W

    更新日期:2017-11-01 00:00:00

  • Socioeconomic and demographic factors that predict where children receive cancer care in Florida.

    abstract::Socioeconomic and demographic factors associated with type of facility (cancer center vs non-cancer center) at which a child with cancer is seen were identified to suggest interventions to increase access to state-of-the-art care. The 2268 children with cancer in Florida (1981-1986) were classified as ever having been...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Roush SW,Krischer JP,Cox MW,Pollock BH

    更新日期:1993-06-01 00:00:00

  • Comparing period prevalences with application to drug utilization.

    abstract::Period prevalence is frequently measured in studies based on administrative data such as that from health maintenance organizations. For example, treated prevalence and drug utilization prevalence are important measures that are typically defined in relationship to a specified time period. Often one wishes to compare ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审


    authors: McFarland BH

    更新日期:1996-04-01 00:00:00

  • Repeatability and validity of the Rose questionnaire for angina pectoris in the Atherosclerosis Risk in Communities Study.

    abstract::Angina pectoris (AP) as determined by the Rose questionnaire was assessed in nearly 16,000 black and white men and women participating in the Atherosclerosis Risk in communities Study, a population study of cardiovascular disease in four communities. The questionnaire was administered at yearly intervals and estimates...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Sorlie PD,Cooper L,Schreiner PJ,Rosamond W,Szklo M

    更新日期:1996-07-01 00:00:00

  • A systematic review of core outcome set development studies demonstrates difficulties in defining unique outcomes.

    abstract:OBJECTIVES:Core outcome set (COS) development often begins with a systematic review to identify outcomes. Reviews frequently show heterogeneity in numbers of outcomes reported across trials. Contributing to this is a lack of a uniform definition for an outcome. This study proposes a first working definition for a uniqu...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Young AE,Brookes ST,Avery KNL,Davies A,Metcalfe C,Blazeby JM

    更新日期:2019-11-01 00:00:00

  • The importance of severity of illness adjustment in predicting adverse outcomes in the Medicare population.

    abstract::The importance of using risk-adjusted mortality rates to measure quality of care is well-established. However, mortality rates may be an insensitive measure of quality for surgical patients since death is a relatively rare outcome. This study used Medicare files to identify, through chart abstraction, clinical postope...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Rosen AK,Ash AS,McNiff KJ,Moskowitz MA

    更新日期:1995-05-01 00:00:00

  • Comparison of "Rose Questionnaire Angina" to exercise thallium scintigraphy: different findings in males and females.

    abstract::Validation of the London School of Hygiene (Rose) Questionnaire with objective measures of myocardial ischemia is incomplete. Therefore, we compared the Rose Questionnaire with exercise thallium-201 myocardial scintigraphy in 147 male and 97 female patients with chest pain referred for clinical exercise testing. Of th...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Garber CE,Carleton RA,Heller GV

    更新日期:1992-07-01 00:00:00

  • Correlation between serial tests made disease probability estimates erroneous.

    abstract:BACKGROUND:The probability of a disease, given the result of two diagnostic tests, can be calculated by multiplying the odds of disease after the first test by the likelihood ratio of the second test. OBJECTIVE:To illustrate the error that occurs when calculating disease probability by combining the results of tests t...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: van Walraven C,Austin PC,Jennings A,Forster AJ

    更新日期:2009-12-01 00:00:00

  • Meaningful changes for the Oxford hip and knee scores after joint replacement surgery.

    abstract:OBJECTIVES:To present estimates of clinically meaningful or minimal important changes for the Oxford Hip Score (OHS) and the Oxford Knee Score (OKS) after joint replacement surgery. STUDY DESIGN AND SETTING:Secondary data analysis of the NHS patient-reported outcome measures data set that included 82,415 patients list...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Beard DJ,Harris K,Dawson J,Doll H,Murray DW,Carr AJ,Price AJ

    更新日期:2015-01-01 00:00:00