How well documented are testing strategies and outcome measurement methods in trials of tests? A comparison of reporting quality in test-treatment and monitoring RCTS
نویسندگان
چکیده
Background Given the advantages of the randomised controlled trial (RCT) design for the evaluation of therapeutic interventions, it is tempting to assume that the same approach must be the gold standard for the evaluation of testing strategies. Such trials present considerable challenges, due to the complex nature of the decision–making process. To interpret how changes in testing strategies create observed effects, trials must pre–specify how test results should inform diagnostic and management decisions and treatment plans.
منابع مشابه
Test-treatment RCTs are susceptible to bias: a review of the methodological quality of randomized trials that evaluate diagnostic tests
BACKGROUND There is a growing recognition for the need to expand our evidence base for the clinical effectiveness of diagnostic tests. Many international bodies are calling for diagnostic randomized controlled trials to provide the most rigorous evidence of impact to patient health. Although these so-called test-treatment RCTs are very challenging to undertake due to their methodological comple...
متن کاملEvaluation of Clinical Trials
In a number of important clinical issues such as evaluation of the efficacy or effectiveness of therapeutic or preventive interventions as well as for comparing the harms of interventions, randomized controlled trials (RCTs) provide the highest levels of evidence, either directly or indirectly. It is obvious that critical appraisal of these studies to assess their validity and precision is of p...
متن کاملBlindness in Randomized Controlled Trials
In combination with randomization, blinding or masking is an important factor in randomized controlled trials (RCTs), particularly in trials that assess therapeutic effects. Here an attempt is made to explain blindness and why it is important. In clinical trials, blinding is defined as the condition imposed on a study in which study participants, health care providers and assessors collecting o...
متن کاملImportant considerations in calculating and reporting of sample size in randomized controlled trials
Background: The calculation of the sample size is one of the most important steps in designing a randomized controlled trial. The purpose of this study is drawing the attention of researchers to the importance of calculating and reporting the sample size in randomized controlled trials. Methods: We reviewed related literature and guidelines and discussed some important issues in s...
متن کاملAdherence to the CONSORT Statement in the Reporting of Randomized Controlled Trials on Pharmacological Interventions Published in Iranian Medical Journals
Background: Among manuscripts submitted to biomedical journals, randomized controlled trials (RCTs) form the backbone of evidence-based medicine. Hence, their protocol should be designed rigorously and their results should be reported clearly. To improve the quality of RCT reporting, researchers developed the CONSORT Statement in 1996 and updated it in 2010. This study was designed to assess th...
متن کامل