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Fallibility of clinical research.

R J Shprintzen1

  • 1Center for Craniofacial Disorders, Montefiore Medical Center, Bronx, New York 10467.

The Cleft Palate-Craniofacial Journal : Official Publication of the American Cleft Palate-Craniofacial Association
|April 1, 1991
PubMed
Summary

Clinical research struggles to answer persistent questions in cleft lip and palate care, such as optimal palate repair timing and the causes of maxillary deficiency. Poor study design and bias hinder progress, impacting patient care.

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Area of Science:

  • Cleft lip and palate research
  • Clinical research methodology
  • Surgical outcomes

Background:

  • Despite extensive literature over 30 years, fundamental questions in cleft lip and palate (CLP) research remain unresolved.
  • Persistent inquiries include determining the optimal age for palate repair and identifying the etiology of maxillary deficiency in CLP patients.

Purpose of the Study:

  • To analyze the persistent challenges and potential reasons for the lack of consensus in clinical research regarding cleft lip and palate.
  • To highlight the impact of research quality, execution, and bias on advancing patient care in this field.

Main Methods:

  • Review of historical and contemporary clinical research questions in cleft lip and palate.
  • Analysis of factors contributing to research limitations, including study design, execution, bias, and question formulation.

Main Results:

  • Many core questions in CLP research have persisted for decades without definitive answers.
  • Factors such as poor study design, misinterpretation of findings, flawed execution, experimenter bias, and even asking the wrong questions impede scientific agreement.
  • These research limitations can significantly affect the application of evidence-based patient care.

Conclusions:

  • The lack of consensus on critical issues in cleft lip and palate research is a significant barrier to advancing patient care.
  • Addressing methodological flaws and biases in clinical research is crucial for progress.
  • Improving research quality and focus is essential to overcome persistent challenges and enhance treatment strategies for individuals with cleft lip and palate.

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