title: Fundamentals of clinical outcomes assessment for spinal disorders: study designs, methodologies, and analyses.
abstract: Study Design A broad narrative review. Objective Management of spinal disorders is continuously evolving, with new technologies being constantly developed. Regardless, assessment of patient outcomes is key in understanding the safety and efficacy of various therapeutic interventions. As such, evidence-based spine care is an essential component to the armamentarium of the spine specialist in an effort to critically analyze the reported literature and execute studies in an effort to improve patient care and change clinical practice. The following article, part one of a two-part series, is meant to bring attention to the pros and cons of various study designs, their methodological issues, as well as statistical considerations. Methods An extensive review of the peer-reviewed literature was performed, irrespective of language of publication, addressing study designs and their methodologies as well as statistical concepts. Results Numerous articles and concepts addressing study designs and their methodological considerations as well as statistical analytical concepts have been reported. Their applications in the context of spine-related conditions and disorders were noted. Conclusion Understanding the fundamental principles of study designs and their methodological considerations as well as statistical analyses can further advance and improve future spine-related research.
authors.affiliation: Department of Orthopaedic Surgery, Boston Children's Hospital, Harvard University Medical School, Boston, Massachusetts, United States ; Harvard Center for Population and Development Studies, Harvard School of Public Health, Boston, Massachusetts, United States ; Department of Orthopedic Surgery, University of Basel, Basel, Switzerland.
authors.forename: Patrick
authors.initials: P
authors.lastname: Vavken
authors.affiliation: Department of Orthopedics, Makati Medical Center, Makati City, Philippines.
authors.forename: Anne Kathleen B
authors.initials: AK
authors.lastname: Ganal-Antonio
authors.affiliation: Department of Orthopaedic Surgery, University of Virginia, Charlottesville, Virginia, United States.
authors.forename: Francis H
authors.initials: FH
authors.lastname: Shen
authors.affiliation: Swedish Neuroscience Institute, Swedish Medical Center, Seattle, Washington, United States.
authors.forename: Jens R
authors.initials: JR
authors.lastname: Chapman
authors.affiliation: Department of Orthopaedics and Traumatology, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China ; The Laboratory and Clinical Research Institute for Pain, The University of Hong Kong, Pokfulam, Hong Kong, SAR, China.
authors.forename: Dino
authors.initials: D
authors.lastname: Samartzis
keywords: analysis; outcomes; personalized; spine; statistics; study design
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