How evident is the evidence?

In this series, we inform and educate our readers about randomized controlled trials and meta-analyses in reproductive medicine as the top-level evidence- generating methods and about their impact on the health of our patients.

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Volume 113, Issue 6, Pages 1091–1092

Authors:

Carlos Simon, M.D., Ph.D.

Abstract:

Randomized-controlled trials (RCTs) and meta-analyses are the pinnacle of evidence-based medicine, enabling identification of the best available diagnostic, interventional, and therapeutic options. These tools help clinicians and policy-makers to set clinical guidelines, but they also represent a double-edged sword: the meaningfulness of RCTs and meta-analyses relies on their quality, performance, and integrity. The present Views and Reviews collection prepared by 18 renowned experts and coordinated by Ben Mol aims to inform and educate our readers about RCTs and meta-analyses in reproductive medicine. The collection begins with the basic features that guarantee the quality of a trial, including protocols, registrations and monitoring, study design and analysis, and reporting standards. Next are discussed the status of planning and coordination of RCTs in different global settings, current unmet needs, and how future studies can better meet these needs, as well as methodologic issues facing different types of RCTs. Finally, insight is provided into the issue of data fabrication and falsification, offering possible solutions to ensure the integrity of RCTs. The challenges and benefits of these crucial evidence-generating tools deserve our attention and education because the findings of RCTs and meta-analyses can directly affect the health of our patients, and when performance and integrity problems exist, the “magic” of these tools disappears—with harmful consequences.

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Fertility and Sterility

Editorial Office, American Society for Reproductive Medicine

Fertility and Sterility® is an international journal for obstetricians, gynecologists, reproductive endocrinologists, urologists, basic scientists and others who treat and investigate problems of infertility and human reproductive disorders. The journal publishes juried original scientific articles in clinical and laboratory research relevant to reproductive endocrinology, urology, andrology, physiology, immunology, genetics, contraception, and menopause. Fertility and Sterility® encourages and supports meaningful basic and clinical research, and facilitates and promotes excellence in professional education, in the field of reproductive medicine.

1 Comments

Go to the profile of James Moruzzi
James Moruzzi 26 days ago

An inexpensive, internet-based, electronic health record (EHR) for use by all fertility clinics could accumulate big data on treatments used and outcomes.  It could solicit patient enrollment in randomized protocols.  It could be a "smart" EHR, and recommend an timely intervention based on published data.

James Moruzzi, MD