scholarly journals Randomized Controlled Trials: Do They Have External Validity for Patients With Multiple Comorbidities?

2006 ◽  
Vol 4 (2) ◽  
pp. 104-108 ◽  
Author(s):  
M. Fortin
Keyword(s):  
Randomized Controlled Trials ◽  
External Validity ◽  
Controlled Trials ◽  
Randomized Controlled

Tools to Assess the External Validity of Randomized Controlled Trials in Systematic Reviews: a Systematic Review of Measurement Properties

2021 ◽  
Author(s):  
Andres Jung ◽  
Julia Balzer ◽  
Tobias Braun ◽  
Kerstin Luedtke
Keyword(s):  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
External Validity ◽  
Measurement Properties ◽  
Controlled Trials ◽  
Measurement Instruments ◽  
Health Measurement ◽  
Quality Of Evidence ◽  
Randomized Controlled

Abstract Background: Internal and external validity are the most relevant components when critically appraising randomized controlled trials (RCTs) for systematic reviews. However, there is no gold standard to assess external validity. This might be related to the heterogeneity of terminology as well as to unclear evidence of the measurement properties of available tools. The aim of this review was to identify tools to assess the external validity of RCTs in systematic reviews and to evaluate the quality of evidence regarding their measurement properties.Methods: A two-phase systematic literature search was performed in four databases: MEDLINE via PubMed, Scopus, PsycINFO via OVID, and CINAHL via EBSCO. First, tools to assess the external validity of RCTs were identified. Second, studies aiming to investigate the measurement properties of these tools were selected. The measurement properties of each included tool were appraised using an adapted version of the COnsensus based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.Results: 34 publications reporting on the development or validation of 26 included tools were included. For 62% of the included tools, there was no evidence of any measurement property. For the remaining tools, reliability was assessed most frequently. Reliability was judged as “sufficient” for three tools (very low quality of evidence). Content validity was rated as “sufficient” for one tool (moderate quality of evidence).Conclusions: Based on these results, no available tool can be fully recommended to assess the external validity of RCTs in systematic reviews. Several steps are required to overcome the identified difficulties to either adapt and validate available tools or to develop a new one. There is a need for more research for this purpose.Trial registration: Prospective registration at Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/PTG4D

Virginia Is Not Switzerland: Challenging the External Validity of the European Randomized Controlled Trials Comparing Laparoscopic Gastric Bypass and Sleeve Gastrectomy

2018 ◽  
Vol 227 (4) ◽  
pp. e76-e77 ◽  
Author(s):  
Guilherme S. Mazzini ◽  
Jad Khoraki ◽  
Matthew G. Brownning ◽  
Luke G. Wolfe ◽  
Gretchen R. Aquilina ◽  
...  
Keyword(s):  
Gastric Bypass ◽  
Sleeve Gastrectomy ◽  
Randomized Controlled Trials ◽  
Laparoscopic Gastric Bypass ◽  
External Validity ◽  
Controlled Trials ◽  
Randomized Controlled

scholarly journals External validity of randomized controlled trials in COPD

2007 ◽  
Vol 101 (6) ◽  
pp. 1313-1320 ◽  
Author(s):  
Justin Travers ◽  
Suzanne Marsh ◽  
Brent Caldwell ◽  
Mathew Williams ◽  
Sarah Aldington ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
External Validity ◽  
Controlled Trials ◽  
Randomized Controlled

scholarly journals The external validity of published randomized controlled trials in primary care

2009 ◽  
Vol 10 (1) ◽  
Author(s):  
Ritu Jones ◽  
Robert O Jones ◽  
Colin McCowan ◽  
Alan A Montgomery ◽  
Tom Fahey
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trials ◽  
External Validity ◽  
Controlled Trials ◽  
Randomized Controlled

Population Diversity Challenge the External Validity of the European Randomized Controlled Trials Comparing Laparoscopic Gastric Bypass and Sleeve Gastrectomy

2019 ◽  
Vol 30 (3) ◽  
pp. 992-1000
Author(s):  
Guilherme S. Mazzini ◽  
Jad Khoraki ◽  
Matthew G. Browning ◽  
Bernardo M. Pessoa ◽  
Luke G. Wolfe ◽  
...  
Keyword(s):  
Gastric Bypass ◽  
Sleeve Gastrectomy ◽  
Randomized Controlled Trials ◽  
Laparoscopic Gastric Bypass ◽  
External Validity ◽  
Population Diversity ◽  
Controlled Trials ◽  
Randomized Controlled

Examining the adherence to CONSORT guidelines and the reporting of the enrollment process in clinical oncology randomized controlled trials: A review of trials published between 2013 and 2015.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14026-e14026
Author(s):  
Sophie Audet ◽  
Catherine Doyle ◽  
Christopher Lemieux ◽  
Julie Lemieux
Keyword(s):  
Randomized Controlled Trials ◽  
Clinical Oncology ◽  
External Validity ◽  
Flow Diagram ◽  
Controlled Trials ◽  
Eligibility Criteria ◽  
Randomized Controlled ◽  
Number Needed To Screen ◽  
Number Of Patients ◽  
Enrollment Process

e14026 Background: Due to eligibility criteria, most, if not all, randomized controlled trials (RCTs) exclude patients at the outset, before randomization. Understanding which patients are excluded is important to evaluate the external validity of the results. The proportion of trials that report the entire flow diagram of patient enrollment, in accordance with the CONSORT 2010 statement, is unknown. Failure to do so makes it more difficult to discuss the generalizability of the trial findings. Methods: We performed the systematic retrieval and analysis of all phases II and III RCTs published in paper form between 2013 and 2015, in four high impact factor journals, in the field of clinical oncology. Our main objective was to determine the proportion of trials that report the number of patients assessed for eligibility before randomization. We further aimed to identify the variables that affect this reporting as well as the reasons for patient exclusion, to calculate the recruitment fraction and the number needed to screen and to determine the proportion of trials that include a discussion on the generalizability of the trial findings. Results: 462 RCTs were reviewed. Among them, 426 (92.2%) included the flow diagram in the article and 224 (48.5%) reported the number of patients assessed for eligibility. This proportion varied significantly between the journals studied, but it did not increase over time. A total of 116 (25.1%) included a discussion of generalizability. Among the trials that reported the entire enrollment process, the reason for patient exclusion could not be found in 50 (22.3%). Conclusions: There is still room for improvement in the reporting of the determinants of external validity in clinical oncology RCTs. Increasing the reporting of the enrollment process could help clinicians and health policy makers establish to whom the results of a trial apply.

scholarly journals Experimental and Non-Experimental Methods in Development Economics: A Porous Dialectic

2015 ◽  
Vol 6 (1) ◽  
Author(s):  
Rajeev Dehejia
Keyword(s):  
Randomized Controlled Trials ◽  
External Validity ◽  
Internal Validity ◽  
Experimental Methods ◽  
Controlled Trials ◽  
Data Sets ◽  
Randomized Controlled ◽  
Nationally Representative ◽  
High Degree ◽  
Internal And External Validity

AbstractThis paper surveys six widely-used non-experimental methods for estimating treatment effects (instrumental variables, regression discontinuity, direct matching, propensity score matching, linear regression and non-parametric methods, and difference-in-differences), and assesses their internal and external validity relative both to each other and to randomized controlled trials. While randomized controlled trials can achieve the highest degree of internal validity when cleanly implemented in the field, the availability of large, nationally representative data sets offers the opportunity for a high degree of external validity using non-experimental methods. We argue that each method has merits in some context and they are complements rather than substitutes.

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