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-seven rehabilitation clinicians of 5 professions from 7 teams (Belgium, Italy, Malaysia, Pakistan, Poland, Puerto Rico, the USA) reviewed 76 RCTs published by main rehabilitation journals exploring 14 domains chosen through consensus and piloting. RESULTS:The response rate was 99%. Inter-rater agreement was moderate/good. All clinicians considered unanimously 12 (16%) RCTs clinically replicable and none not replicable. At least one "absent" information was found by all participants in 60 RCTs (79%), and by a minimum of 85% in the remaining 16 (21%). Information considered to be less well described (8-19% "perfect" information) included two providers (skills, experience) and two delivery (cautions, relationships) items. The best described (50-79% "perfect") were the classic methodological items included in CONSORT (descending order: participants, materials, procedures, setting, and intervention). CONCLUSION:Clinical replicability must be considered in RCTs reporting, particularly for complex interventions. Classical methodological checklists such as CONSORT are not enough, and also Template for Intervention Description and Clinical replication do not cover all the requirements. This study supports the need for field-specific checklists.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
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.doi
10.1016/j.jclinepi.2019.06.008subject
Has Abstractpub_date
2019-10-01 00:00:00pages
108-117eissn
0895-4356issn
1878-5921pii
S0895-4356(19)30315-4journal_volume
114pub_type
杂志文章abstract: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 s...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2008.06.017
更新日期:2009-04-01 00:00:00
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
更新日期:1995-07-01 00:00:00
abstract:OBJECTIVE:The Mini-Mental State Examination (MMSE) is used to estimate current cognitive status and as a screen for possible dementia. Missing item-level data are commonly reported. Attention to missing data is particularly important. However, there are concerns that common procedures for dealing with missing data, for...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2010.10.011
更新日期:2011-07-01 00:00:00
abstract::Plasma fibrinogen was measured in a sample of 8824 men and women aged 40-59 years participating in the Scottish Heart Health Study, and related to cardiovascular risk factors. Women had higher fibrinogen levels than men. In both sexes, multivariate analysis showed that fibrinogen was positively associated with age, sm...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(90)90075-z
更新日期:1990-01-01 00:00:00
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
更新日期:1992-06-01 00:00:00
abstract:OBJECTIVES:To ascertain the smallest amounts of change for the three Manchester-Oxford Foot Questionnaire (MOXFQ) domains that are likely to be clinically meaningful and beyond measurement error for conditions affecting the foot/ankle. Estimates were compared with those from the Short-Form 36 (SF-36). STUDY DESIGN AND...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2014.01.003
更新日期:2014-06-01 00:00:00
abstract:OBJECTIVES:To identify, describe, and map contemporary nutrition guidelines (NGs) from reviews that used the Appraisal of Guidelines, Research and Evaluation (AGREE) tool. STUDY DESIGN AND SETTING:We performed an overview of reviews that systematically assessed the quality of NGs using the AGREE tool. We searched MEDL...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2018.08.018
更新日期:2018-12-01 00:00:00
abstract:OBJECTIVES:The aim of the study was to assess the completeness of reporting of methods in overviews. STUDY DESIGN AND SETTING:Assessment of the adequacy of reporting of methods in a random sample of 50 overviews was based on a published framework of methods for conducting overviews. Descriptive summary statistics were...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2019.09.025
更新日期:2020-02-01 00:00:00
abstract:BACKGROUND:We aimed to compare the judgmental and mathematical approaches in weighting the Pediatric Ulcerative Colitis Activity Index (PUCAI). METHODS:The PUCAI was previously weighted mathematically using multivariate regression modeling on 157 children with ulcerative colitis (UC). Independently, a Delphi group of ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2008.09.008
更新日期:2009-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:When contamination is present, randomization on a patient level leads to dilution of the treatment effect. The usual solution is to randomize on a cluster level, but at the cost of efficiency and more importantly, this may introduce selection bias. Furthermore, it may slow down recruitment in ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2005.10.003
更新日期:2006-04-01 00:00:00
abstract:OBJECTIVES:To assess differences between three different decision-making approaches in the method of panel diagnosis as reference standard in diagnostic research. STUDY DESIGN AND SETTING:Within a diagnostic study, the prevalence of heart failure (HF) and chronic obstructive pulmonary disease (COPD) was compared using...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2014.09.020
更新日期:2015-04-01 00:00:00
abstract:OBJECTIVE:Cases and controls should be chosen from the same base population to reduce selection bias in case-control studies. For hospital cases, we examined how inferences drawn from a case-control study can differ by choice of hospital- vs. community-based controls. STUDY DESIGN AND SETTINGS:We used data from a case...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2009.11.006
更新日期:2010-08-01 00:00:00
abstract:OBJECTIVES:Model specification-what adjusting variables are analytically modeled-may influence results of observational associations. We present a standardized approach to quantify the variability of results obtained with choices of adjustments called the "vibration of effects" (VoE). STUDY DESIGN AND SETTING:We estim...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2015.05.029
更新日期:2015-09-01 00:00:00
abstract::Both spontaneous reports and single outcome studies may distort the overall safety evaluation of drugs. We identified epidemiologic studies, published from January 1970 to December 1995, that investigated the association of serious adverse effects with aspirin, diclofenac, acetaminophen, and dipyrone to determine and ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(98)00076-6
更新日期:1998-12-01 00:00:00
abstract:OBJECTIVE:To illustrate and discuss current and proposed new concepts of effect size (ES) quantification and significance, with a focus on statistical and clinical/subjective interpretation and supported by empirical examples. STUDY DESIGN AND SETTINGS:Different methods for determining minimal clinically important dif...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2016.11.016
更新日期:2017-02-01 00:00:00
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
更新日期:2006-05-01 00:00:00
abstract:OBJECTIVES:Researchers need to be confident about the reliability of epidemiologic studies that quantify medication use through self-report. Some evidence suggests that psychiatric medications are systemically under-reported. Modern record linkage enables validation of self-report with national prescribing data as gold...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2017.10.013
更新日期:2018-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:There is considerable actual and potential waste in research. Using evidence-based research (EBR) can ensure the value of a new study. The aim of this article, the third in a series, is to describe an EBR approach to putting research results into context. STUDY DESIGN AND SETTING:EBR is the us...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2020.07.021
更新日期:2021-01-01 00:00:00
abstract::Whether or not to treat patients with non-rheumatic atrial fibrillation with anticoagulants to prevent embolic stroke is a dilemma for physicians. If randomized trials, currently underway, demonstrate a beneficial effect, the dilemma will not be solved because not all of the relevant factors can be addressed by trials...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(91)90219-y
更新日期:1991-01-01 00:00:00
abstract::The duration of protection offered by Pap screening for cervical cancer was examined using data on 101 cases of invasive cervical cancer and 396 controls from a Maryland case-control study. Receipt of a Pap test up to 4 years ago afforded significant protection, compared to women screened 11 or more years ago, or neve...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(89)90166-2
更新日期:1989-01-01 00:00:00
abstract:OBJECTIVE:The framework consists of cohort or case-series studies with intermittent exposure and two types of events. The aim is to define and estimate an association measure between the exposure and the occurrence of one type of event rather than the other. STUDY DESIGN AND SETTING:The model and the estimation method...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2006.07.014
更新日期:2007-04-01 00:00:00
abstract:OBJECTIVE:To assess the effects of abbreviated literature searches on evidence syntheses conclusions. STUDY DESIGN AND SETTING:We randomly selected 60 Cochrane reviews of clinical interventions and repeated literature searches using 14 abbreviated approaches (combinations of MEDLINE, Embase, CENTRAL with and without s...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,meta分析
doi:10.1016/j.jclinepi.2018.05.022
更新日期:2018-10-01 00:00:00
abstract:OBJECTIVE:Estimates of minimal clinically important improvements (MCIIs) are larger among patients with higher values at baseline, suggesting that these patients require larger changes to appreciate improvements. We examined if baseline dependency of MCIIs was associated with specific patients across three measures, or...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2013.10.025
更新日期:2014-06-01 00:00:00
abstract:OBJECTIVES:The objective of the study is to estimate the proportion of statistically significant survival improvements reported in randomized trials of cancer treatments that are also compatible with a clinically negligible benefit. STUDY DESIGN AND SETTING:This is a cross-sectional study of reports of randomized clin...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2020.06.026
更新日期:2020-11-01 00:00:00
abstract:BACKGROUND:Once a proposed topic has been identified for a systematic review and has undergone a question formulation stage, a protocol must be developed that specifies the scope and research questions in detail and outlines the methodology for conducting the systematic review. RATIONALE:Framework modifications are of...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2017.06.013
更新日期:2017-10-01 00:00:00
abstract:OBJECTIVES:To evaluate the presence of extreme findings and fluctuation in effect size in endocrinology. STUDY DESIGN AND SETTINGS:We systematically identified all meta-analyses published in 2014 in the field of endocrinology. Within each meta-analysis, the effect size of the primary binary outcome was compared across...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.jclinepi.2015.10.015
更新日期:2016-04-01 00:00:00
abstract:OBJECTIVES:The classical diagnostic cross-sectional study has a focus on one disease only. Generalist clinicians, however, are confronted with a wide range of diagnoses. We propose the "comprehensive diagnostic study design" to evaluate diagnostic tests regarding more than one disease outcome. STUDY DESIGN AND SETTING...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2013.05.019
更新日期:2014-02-01 00:00:00
abstract:OBJECTIVES:N-of-1 trials can be aggregated to estimate population treatment effects using hierarchical Bayesian models. It is very important to report core items in hierarchical Bayesian analysis. In this study, we assessed reporting of items in hierarchical Bayesian analysis for aggregating N-of-1 trials to estimate p...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2016.02.023
更新日期:2016-08-01 00:00:00
abstract::Health screening is defined as the use of a test or a series of tests to detect unrecognized health risks or preclinical disease in apparently healthy populations to permit prevention and timely intervention. A health screening strategy consists of the sequence of a screening test, confirmatory test(s), and finally, t...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2010.09.009
更新日期:2011-03-01 00:00:00
abstract::The objective of this study was to compare the relative responsiveness of a condition-specific spinal stenosis measure and two generic health status measures for outcome assessment of surgery for degenerative lumbar spinal stenosis, and to examine whether responsiveness statistics and measures of the ability to distin...
journal_title:Journal of clinical epidemiology
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/0895-4356(95)00054-2
更新日期:1995-11-01 00:00:00