Orthopaedic Research



Orthopaedic Research


Vinod Dasa, MD, FAAOS

Raveendhara R. Bannuru, MD, PhD

Jessica C. Rivera, MD, PhD, FAAOS


Dr. Dasa or an immediate family member is a member of a speakers’ bureau or has made paid presentations on behalf of Bioventus and Pacira Biosciences; serves as a paid consultant to or is an employee of Bioventus, Cymedica, and Pacira Biosciences; has stock or stock options held in Cymedica, Doc Social, Goldfinch Consulting, mymedicalimages. com, Ortho Lazer, and SIGHT Medical; and has received research or institutional support from Cartiheal and Cymedica. Dr. Rivera or an immediate family member is a member of a speakers’ bureau or has made paid presentations on behalf of NuVasive and serves as a board member, owner, officer, or committee member of American Academy of Orthopaedic Surgeons, Limb Lengthening and Reconstruction Society, and Orthopaedic Research Society. Neither Dr. Bannuru nor any immediate family member has received anything of value from or has stock or stock options held in a commercial company or institution related directly or indirectly to the subject of this chapter.





ABSTRACT

Evaluating the quality and relevance of research is a foundational principle of any healthcare provider. It is important to review the tools and mechanisms to evaluate the various types of research and their quality. There are multiple types of publications, with open access articles becoming more and more popular. Orthopaedic surgeons must be aware of the benefits and pitfalls of these new options. Clinical practice guidelines are an important part of clinical management and are important in healthcare policy; orthopaedic surgeons must be able to evaluate the development and interpretation of guidelines.

Keywords: basic science; clinical practice guidelines; clinical science; translational research


Introduction

Basic science data in their fundamental state would seem to be universally understood and appreciated, yet it has been shown that what are thought of as objective and unbiased data can be interpreted through a variety of perspectives and paradigms. There has never been a more pressing time for scientists, clinicians, and the general public to appreciate the complexity and fragility of science. It must be understood that methodology, design, analysis, and interpretation across all disciplines in a manner that serves the public good will allow advancement along a meaningful and unbiased path.


Importance of Clinical and Basic Science Research in the Field of Orthopaedics

The notion of transferring knowledge gained in the laboratory to the bedside is a foundational component of medical research.1 Orthopaedic surgery has seen tremendous advances based on laboratory and bench science. Examples range from the development of new biomaterials, including ceramic to polyethylene with implant survivorship lasting 35 years, to the elucidation of mechanisms of tissue healing that has informed best practices for rehabilitation.2 More recently, increasing interest in the biologic aspects of the musculoskeletal system has informed the development of novel therapeutic advances focused on enhancing the biologic properties of healing. From platelet-rich plasma to gene therapy for chronic conditions such as arthritis and basic and translational research, these new approaches will pave the way for modern biologic treatments for conditions that have long been prevented from robust nonsurgical treatments.3


Clinical Translation of Basic Science to the Bedside

There are many types of research involved in understanding a clinical disorder, developing and evaluating possible therapeutic agents, implementing a new therapy, studying the outcomes, and even compiling guidelines for prevention and treatment. This concept is termed benchtop to bedside. Basic science research starts at the benchtop, using laboratory methods to study fundamental mechanisms of a disease. Genetic, molecular, and cellular pathways may be elucidated using basic science methods. Underlying knowledge gained from basic science informs understanding of disease pathophysiology and therapeutic design.


Preclinical research is often also considered basic science but links fundamental laboratory findings with clinical disease. In vitro models, such as cell and tissue cultures, small animal models, and even simulated modeling all are types of preclinical research that link benchtop findings to better understand how diseases can be managed. Preclinical research also includes studying disease and therapies in large animals. Both in vitro or small animal models and large animal models are required to study a new therapy, including new drugs, prior to human testing. Once preclinical research results in a new therapy that is well tested in these models, early clinical research can begin.

Each of these steps from very basic research to study of human subjects must be linked toward a common goal to advance the treatment of a human disease or improve public health. This is the essence of clinical translation or translational science. The National Institutes of Health National Center for Advancing Translational Sciences defines translational science as the “field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process.”4 By focusing on translation, basic and clinical researchers avoid performing research for the sake of research, but instead for an end goal toward improving human and public health.


Knowing the Specifics of How Research is Conducted and How to Read and Interpret Clinical Studies

Reviewing and synthesizing research is critical for any medical professional to not only remain aware of current trends but to ensure a proper understanding of foundational principles within orthopaedics. For potential researchers, understanding historical work and current practices points to knowledge gaps and frames new questions and areas of investigation to support the translation of basic science to clinical care.

Healthcare professionals may read studies for a variety of reasons but require competencies for lifelong learning. These include critical and creative thinking, problem analysis, gathering and organizing information, abstract reasoning, interpretive and assessment skills, insight and intuition in generating knowledge, effective communication, and information literacy.5

Reading and interpreting scientific literature requires a deliberate and methodologic approach. The type of literature sought will depend on whether the learner is looking for research ideas, enhancing knowledge on a given topic, or looking for answers to a particular problem. Each reader has a different goal in mind; thus, understanding how research is structured and organized is important to the ultimate goal. Most clinical studies are divided into a common organizational scheme starting with a title, abstract, introduction, materials/methods, results, discussion/conclusion, and references. Although the introduction and discussion contain the authors’ perspective of the current state of science and how the presented research adds to it, readers must be critical of the research methods and results to make their own conclusions and determine how the research applies to their own practice. Understanding the components of each section and what they include will be important to an efficient and thorough review of information.6


Importance of Bias and Level of Evidence to Interpret Study Conclusions

Classifying scientific studies by level of quality, or level of evidence, allows better evaluation of the potential for bias.7 Bias is often introduced in methodologically weak studies such as case reports and expert opinion. As study design and rigor improve, the risk of bias diminishes. Biases can occur at all stages of research from trial design to data analysis; therefore, it is important to appreciate the potential for bias and its effect on interpretation of the results.8


Levels of Evidence

Medical science has evolved well beyond examining an experimental treatment compared with a placebo control. As big data, health economics, and many other new investigational disciplines become increasingly important, a framework to judge the quality and strength of the research is needed. Table 1 outlines the complexity of research categories and lists the levels of evidence based on the type and goals of the research endeavor.9


Systematic Reviews and Meta-analyses

An estimated 2.5 million new scientific papers are published annually.10 The resulting overflow of information means that most professionals cannot stay up to date in their fields simply by reading journals. Systematic reviews and meta-analyses offer the opportunity to evaluate summary statistics of large amounts of data. In a well-done meta-analysis, resources are rigorously reviewed and screened for quality, filtering out data that may be unreliable or inaccurate.

Meta-analysis is a complex and powerful statistical procedure that combines the results of different eligible studies to generate a single estimate of the major effect with enhanced precision. Some applications of systematic review and meta-analyses are as follows: (1) Up-to-date meta-analyses provide a comprehensive summary of existing clinical evidence and can lay a groundwork for future research. (2) Clinical practice guideline development is dependent on meta-analytic data. (3) Meta-analytic data

are often used in the FDA approval process. (4) Meta-analytic data can result in the removal of a treatment from the market. Systematic reviews and meta-analyses that include high level studies are considered level I evidence.







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May 1, 2023 | Posted by in ORTHOPEDIC | Comments Off on Orthopaedic Research

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