Primary Outcomes Reporting in Trials (PORTal): a systematic review of inadequate reporting in pediatric randomized controlled trials.


OBJECTIVE:Conduct a systematic review of pediatric randomized controlled trials (RCTs) published in high-impact journals to assess the reporting of primary outcomes and the psychometric properties of their measures. STUDY DESIGN AND SETTING:Systematic review with screening and simultaneous data extraction conducted by two independent reviewers. Electronic searches of six general medicine and four pediatric journals were conducted in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) databases. RCTs of a single phase/step in a single publication, published in English between 2000 and 2010 with participants less than 21 years of age were included. RESULTS:A random sample of 20% (n = 445) of 2,229 initial references was screened and 206 (46%) met inclusion criteria. Half (48.5%) of included studies reported a singular primary outcome, 27% did not identify any primary outcome, and 24% identified multiple primary outcomes (range 2-20). Twenty-one trials used an instrument to measure their primary outcome, but only 7 (33%) reported its psychometric properties. CONCLUSION:Pediatric trials published in top medical journals have inadequate reporting of their primary outcomes and the psychometric properties of their outcome measures. Whether the issue is one of poor reporting and/or poor validation will be further investigated.


J Clin Epidemiol


Bhaloo Z,Adams D,Liu Y,Hansraj N,Hartling L,Terwee CB,Vohra S




Has Abstract


2017-01-01 00:00:00












  • The qualification period.

    abstract::For randomized trials that do not require prompt onset of therapy, a pre-admission preparation, called the qualification period, can deal with certain customary difficulties in design, analysis, and ethics. For the patients' baseline state, the qualification period can be used to "wash out" effects of previous treatme...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Knipschild P,Leffers P,Feinstein AR

    更新日期:1991-01-01 00:00:00

  • Lack of correlation between clinic and 24 hour ambulatory blood pressure in subjects participating in a therapeutic drug trial.

    abstract::Although previous studies document that blood pressure measured in the clinic may differ significantly from blood pressure recorded over 24 hours, the impact of these differences on patient selection for therapeutic drug trials is unknown. A placebo controlled double-blind evaluation of an experimental antihypertensiv...

    journal_title:Journal of clinical epidemiology

    pub_type: 临床试验,杂志文章


    authors: Gradman AH,Pangan P,Germain M

    更新日期:1989-01-01 00:00:00

  • Mortality, hospital discharges, and case fatality for pulmonary embolism in the Twin Cities: 1980-1995.

    abstract::Pulmonary embolism (PE) causes substantial morbidity and mortality, but little information is available regarding recent secular trends for PE. This study determined trends for PE in adults ages 30 to 84 years in the Minneapolis-St. Paul metropolitan area from 1980 to 1995. The age-adjusted mortality rate for PE decre...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Janke RM,McGovern PG,Folsom AR

    更新日期:2000-01-01 00:00:00

  • A nested case-control study of influenza vaccination was a cost-effective alternative to a full cohort analysis.

    abstract:OBJECTIVE:In the absence of trial results that are applicable to the target population, nested case-control studies might be an alternative to full-cohort analysis. We compared relative and absolute estimates of associations in an influenza vaccine study using both designs. STUDY DESIGN AND SETTING:Data from elderly p...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Hak E,Wei F,Grobbee DE,Nichol KL

    更新日期:2004-09-01 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

  • Headache classification based on questionnaire data: which symptoms are especially suitable?

    abstract::In replication of two recent studies, it was intended to show that headache symptoms obtained by means of questionnaires fit a categorial model, provided that appropriate methods of data analysis are used. In addition, the questions which are best posed to obtain a succinct classification should be determined. Configu...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Köhler T,Eisentraut R,Graeber E

    更新日期:1995-06-01 00:00:00

  • Odds ratio estimation in a steady-state population.

    abstract::A three-state Markov process is used to model a steady-state population. The classical P = ID equation is derived, as well as a number of identities originally reported by Miettinen (Am J Epidemiol 1976; 103: 226-235) and Freeman and Hutchison (Am J Epidemiol 1980; 112: 707-723. Ibid. 1986; 124: 134-149). Using theore...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Newman SC

    更新日期:1988-01-01 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


    authors: Schmidt JG

    更新日期:1990-01-01 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


    authors: Deyo RA,Cherkin DC,Ciol MA

    更新日期:1992-06-01 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

  • 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


    authors: Shaper AG,Wannamethee SG,Whincup PH

    更新日期:2004-02-01 00:00:00

  • Heritabilities and shared environmental effects were estimated from household clustering in national health survey data.

    abstract:OBJECTIVES:The relative contributions of genetic and environmental variables to within-household clustering of quantitative traits in household surveys are poorly characterized. We estimated shared genetic and shared environmental contributions to within-household correlation for anthropometric variables and cardiovasc...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Saunders CL,Gulliford MC

    更新日期:2006-11-01 00:00:00

  • Insufficient cross-cultural adaptations and psychometric properties for many translated health assessment scales: a systematic review.

    abstract:OBJECTIVES:If researchers want to assess reliably different aspects of general health in the migrant populations, they need translations of internationally used health assessment scales with appropriate cross-cultural adaptations and satisfactory psychometric properties. A systematic review was performed to assess the ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审


    authors: Uysal-Bozkir Ö,Parlevliet JL,de Rooij SE

    更新日期:2013-06-01 00:00:00

  • Diagnostic certainty and potential for misclassification in exocrine pancreatic cancer. PANKRAS I Project Investigations.

    abstract::Whereas over the last decade epidemiologic studies on exocrine pancreatic cancer (EPC) continued to show a remarkable heterogeneity in diagnostic criteria applied to define caseness, the actual magnitude and consequences of misclassification remain largely unexplored. The objectives were: (1) to estimate the degree of...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Porta M,Malats N,Piñol JL,Rifà J,Andreu M,Real FX

    更新日期:1994-09-01 00:00:00

  • Bias in estimates of confidence intervals for health outcome report cards.

    abstract::Health researchers commonly use logistic regression when profiling health providers. Data from the patients treated by the providers are used to construct models predicting the expected number of outcomes for providers and the ratio of observed to expected outcomes (O/E ratio) used as a risk-adjusted measure of provid...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Faris PD,Ghali WA,Brant R

    更新日期:2003-06-01 00:00:00

  • Factors associated with errors in death certificate completion. A national study in Taiwan.

    abstract::To identify characteristics of certifying physicians and the deceased that are associated with errors in death certificate completion in Taiwan, we retrospectively reviewed 4123 systematically sampled death certificates issued in 1994. Multivariate analyses were used to assess the associations of various characteristi...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Lu TH,Shau WY,Shih TP,Lee MC,Chou MC,Lin CK

    更新日期:2001-03-01 00:00:00

  • Handling the reflective-formative measurement conundrum: a practical illustration based on sustainable employability.

    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


    authors: Fleuren BPI,van Amelsvoort LGPM,Zijlstra FRH,de Grip A,Kant I

    更新日期:2018-11-01 00:00:00

  • Analysis of nonresponse bias in a population-based case-control study on lung cancer.

    abstract::The objective of this study was to identify characteristics of nonrespondents and late respondents in a population-based case-control study on lung cancer conducted in the city of Turin (Italy). Information about demographic and socioeconomic variables of 634 cases and 859 controls who responded to an interview, as we...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Richiardi L,Boffetta P,Merletti F

    更新日期:2002-10-01 00:00:00

  • Public and private hypotheses.

    abstract::The uses of hypothesis in scientific medicine and in clinical medicine are broadly similar; but they differ in subtle but important logical details. The key distinction is that scientific medicine deals with broad ("public") hypotheses about entire populations; and the predominant problem of inference is statistics in...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Murphy EA

    更新日期:1989-01-01 00:00:00

  • Non-Cochrane vs. Cochrane reviews were twice as likely to have positive conclusion statements: cross-sectional study.

    abstract:OBJECTIVES:To determine which factors predict favorable results and positive conclusions in systematic reviews (SRs) and to assess the level of agreement between SR results and conclusions. STUDY DESIGN AND SETTING:A sample of 296 English SRs indexed in MEDLINE (November, 2004) was obtained. Two investigators independ...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Tricco AC,Tetzlaff J,Pham B,Brehaut J,Moher D

    更新日期:2009-04-01 00:00:00

  • Assessing risk of bias in prevalence studies: modification of an existing tool and evidence of interrater agreement.

    abstract:OBJECTIVE:In the course of performing systematic reviews on the prevalence of low back and neck pain, we required a tool to assess the risk of study bias. Our objectives were to (1) modify an existing checklist and (2) test the final tool for interrater agreement. STUDY DESIGN AND SETTING:The final tool consists of 10...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Hoy D,Brooks P,Woolf A,Blyth F,March L,Bain C,Baker P,Smith E,Buchbinder R

    更新日期:2012-09-01 00:00:00

  • Clinical correlates of advanced retinopathy in type II diabetic patients: implications for screening. The CODIAB-INSERM-Zeneca Pharma Study Group.

    abstract::The clinical correlates of advanced retinopathy were determined in a sample of 427 type II diabetic outpatients, aged 35 to 74 years, recruited in eight centers from all parts of France. The presence of retinopathy was assessed by fluorescein angiography with centralized interpretation. Advanced retinopathy (prolifera...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,多中心研究


    authors: Delcourt C,Villatte-Cathelineau B,Vauzelle-Kervroedan F,Papoz L

    更新日期:1996-06-01 00:00:00

  • The next stage: molecular epidemiology.

    abstract::The traditional approach in epidemiology of relating exposure to an environmental agent such as a drug or infective agent has been to measure an overall risk (i.e., average and then "adjust risk for demographic variables and other confounders"). An attempt is sometimes made to define a "susceptible" subgroup. The anal...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Shpilberg O,Dorman JS,Ferrell RE,Trucco M,Shahar A,Kuller LH

    更新日期:1997-06-01 00:00:00

  • Some methodologic issues in analyzing data from a randomized adolescent tobacco and alcohol use prevention trial.

    abstract::Three issues concerning the design and analysis of randomized behavioral intervention studies are illustrated and discussed within the framework of a tobacco and alcohol prevention trial among migrant Latino adolescents. The first issue arises when subjects are randomized in clusters rather than individually. Because ...

    journal_title:Journal of clinical epidemiology

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: Slymen DJ,Elder JP,Litrownik AJ,Ayala GX,Campbell NR

    更新日期:2003-04-01 00:00:00

  • Comparing clinical information with claims data: some similarities and differences.

    abstract::How well can hospital discharge abstracts be used to estimate patient health status? This paper compares information on comorbidity obtained from hospital discharge abstracts for patients undergoing prostatectomy or cholecystectomy at a Winnipeg teaching hospital with clinical data on preoperative medical conditions p...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Roos LL,Sharp SM,Cohen MM

    更新日期:1991-01-01 00:00:00

  • An e-mail survey identified unpublished studies for systematic reviews.

    abstract:BACKGROUND AND OBJECTIVE:A large number of trials remain difficult to locate or unpublished for systematic reviews. The objective of this article was to determine the usefulness of making e-mail contact with authors of clinical trials and literature reviews found in MEDLINE to identify unpublished or difficult to locat...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章


    authors: Reveiz L,Cardona AF,Ospina EG,de Agular S

    更新日期:2006-07-01 00:00:00

  • A critical review of methods for the assessment of patient-level interactions in individual participant data meta-analysis of randomized trials, and guidance for practitioners.

    abstract:OBJECTIVE:Treatments may be more effective in some patients than others, and individual participant data (IPD) meta-analysis of randomized trials provides perhaps the best method of investigating treatment-covariate interactions. Various methods are used; we provide a comprehensive critique and develop guidance on meth...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审


    authors: Fisher DJ,Copas AJ,Tierney JF,Parmar MK

    更新日期:2011-09-01 00:00:00

  • Describing reporting guidelines for health research: a systematic review.

    abstract:OBJECTIVE:To describe the process of development, content, and methods of implementation of reporting guidelines for health research. STUDY DESIGN AND SETTING:A systematic review of publications describing health research reporting guidelines developed using consensus. RESULTS:Eighty-one reporting guidelines for heal...

    journal_title:Journal of clinical epidemiology

    pub_type: 杂志文章,评审


    authors: Moher D,Weeks L,Ocampo M,Seely D,Sampson M,Altman DG,Schulz KF,Miller D,Simera I,Grimshaw J,Hoey J

    更新日期:2011-07-01 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

  • 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