Abstract:
:Results from pragmatic trials should reflect the comparative treatment effects encountered in patients in real-life clinical practice to guide treatment decisions. Therefore, pragmatic trials should focus on outcomes that are relevant to patients, clinical practice, and treatment choices. This sixth article in the series (see Box) discusses different types of outcomes and their suitability for pragmatic trials, design choices for measuring these outcomes, and their implications and challenges. Measuring outcomes in pragmatic trials should not interfere with real-world clinical practice to ensure generalizability of trial results, and routinely collected outcomes should be prioritized. Typical outcomes include mortality, morbidity, functional status, well-being, and resource use. Surrogate endpoints are typically avoided as primary outcome. It is important to measure outcomes over a relevant time horizon and obtain valid and precise results. As pragmatic trials are often open label, a less subjective outcome can reduce bias. Methods that decrease bias or enhance precision of the results, such as standardization and blinding of outcome assessment, should be considered when a high risk of bias or high variability is expected. The selection of outcomes in pragmatic trials should be relevant for decision making and feasible in terms of executing the trial in the context of interest. Therefore, this should be discussed with all stakeholders as early as feasible to ensure the relevance of study results for decision making in clinical practice and the ability to perform the study.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Welsing PM,Oude Rengerink K,Collier S,Eckert L,van Smeden M,Ciaglia A,Nachbaur G,Trelle S,Taylor AJ,Egger M,Goetz I,Work Package 3 of the GetReal Consortium.doi
10.1016/j.jclinepi.2016.12.022subject
Has Abstractpub_date
2017-10-01 00:00:00pages
99-107eissn
0895-4356issn
1878-5921pii
S0895-4356(17)30481-Xjournal_volume
90pub_type
杂志文章abstract:OBJECTIVES:To explore how the concept of randomization is described by clinicians and understood by patients in randomized controlled trials (RCTs) and how it contributes to patient understanding and recruitment. STUDY DESIGN AND SETTING:Qualitative analysis of 73 audio recordings of recruitment consultations from fiv...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jclinepi.2018.02.018
更新日期:2018-07-01 00:00:00
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
doi:10.1016/s0895-4356(96)00275-2
更新日期:1996-12-01 00:00:00
abstract::Coronary heart disease (CHD) is an imprecise, inappropriate monitor of atherosclerosis severity and by inapplicable extrapolation CHD risk factors are incorrectly assumed to be causes of atherosclerosis. Taking into account (1) the misuse and substantial diagnostic error of CHD, (2) errors in determining the prevalenc...
journal_title:Journal of clinical epidemiology
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doi:10.1016/0895-4356(90)90231-d
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abstract:OBJECTIVES:Recent studies suggest that rating clinical marker states (CMS) does not improve the measurement properties of the standard gamble (SG) and only slightly improves those of the feeling thermometer (FT). The poor intrarater (test-retest) reliability of CMS may explain their meager performance. Further, lack of...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jclinepi.2007.03.010
更新日期:2007-12-01 00:00:00
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doi:10.1016/0895-4356(96)00134-5
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更新日期:2014-05-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2011.07.010
更新日期:2011-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:To determine the accuracy of recently introduced International Classification of Diseases Ninth Revision (ICD-9) procedure and Current Procedural Terminology (CPT) codes designed for injection or infusion of thrombolytic agents. MATERIALS AND METHODS:We determined the accuracy of ICD-9 procedu...
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更新日期:2006-08-01 00:00:00
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journal_title:Journal of clinical epidemiology
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doi:10.1016/j.jclinepi.2008.09.014
更新日期:2009-06-01 00:00:00
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pub_type: 杂志文章
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更新日期:1991-01-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2008.11.005
更新日期:2009-08-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2003.07.001
更新日期:2004-02-01 00:00:00
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doi:10.1016/j.jclinepi.2019.06.002
更新日期:2019-11-01 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 ...
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pub_type: 杂志文章
doi:10.1016/j.jclinepi.2008.09.008
更新日期:2009-07-01 00:00:00
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pub_type: 杂志文章
doi:10.1016/0895-4356(96)00116-3
更新日期:1996-09-01 00:00:00
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pub_type: 杂志文章
doi:10.1016/j.jclinepi.2017.06.020
更新日期:2018-05-01 00:00:00
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pub_type: 杂志文章
doi:10.1016/j.jclinepi.2008.02.007
更新日期:2009-04-01 00:00:00
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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
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更新日期:2001-05-01 00:00:00
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doi:10.1016/j.jclinepi.2006.03.003
更新日期:2008-05-01 00:00:00
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pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1993-12-01 00:00:00
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pub_type: 杂志文章,评审
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更新日期:2010-11-01 00:00:00
abstract::Associations of baseline one-hour postload plasma glucose with 22-year coronary heart disease, stroke, cardiovascular diseases, and all cause mortality were assessed in five age-specific cohorts of nondiabetic men and women from the Chicago Heart Association Detection Project in Industry: 10,269 men ages 18-39 years; ...
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更新日期:1997-12-01 00:00:00
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doi:10.1016/j.jclinepi.2020.09.026
更新日期:2021-01-01 00:00:00
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pub_type: 临床试验,杂志文章
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abstract::In this project, we set out to identify ways to increase the uptake of core outcome sets in clinical research. In doing so, we uncovered a growing recognition, across many different health care sectors, of the need for common, relevant outcomes to improve the quality of decision-making. This has led to a plethora of p...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
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更新日期:2019-12-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:There is a pressing need for evidence-based interventions to address the devastating clinical and public health effects of the coronavirus disease 2019 (COVID-19) pandemic. The number of registered trials related to COVID-19 is increasing by the day. The objective of this study was to describe ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2020.06.005
更新日期:2020-09-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2013.01.016
更新日期:2013-08-01 00:00:00
abstract:OBJECTIVES:Emergency department triage systems can be considered prediction rules with an ordinal outcome, where different directions of misclassification have different clinical consequences. We evaluated strategies to compare the performance of triage systems and aimed to propose a set of performance measures that sh...
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pub_type: 杂志文章
doi:10.1016/j.jclinepi.2017.11.004
更新日期:2018-02-01 00:00:00