Randomized Clinical Trials and Observational Tribulations: Providing Clinical Evidence for Personalized Surgical Pain Management Care Models.

Autor:	Abraham I; Pharmacy Medicine, and Clinical Translational Sciences, University of Arizona, Roy P. Drachman Hall, Rm. B306H, Tucson, AZ 85721, USA., Lewandrowski KU; Center for Advanced Spine Care of Southern Arizona, Tucson, AZ 85712, USA.; Department of Orthopaedics, Fundación Universitaria Sanitas, Bogotá 111321, Colombia.; Department of Orthopedics, Hospital Universitário Gaffre e Guinle, Universidade Federal do Estado do Rio de Janeiro, Rio de Janeiro 20270-004, Brazil., Elfar JC; Department of Orthopaedic Surgery, College of Medicine-Tucson Campus, Health Sciences Innovation Building (HSIB), University of Arizona, 1501 N. Campbell Avenue, Tower 4, 8th Floor, Suite 8401, Tucson, AZ 85721, USA., Li ZM; Department of Orthopaedic Surgery, College of Medicine-Tucson Campus, Health Sciences Innovation Building (HSIB), University of Arizona, 1501 N. Campbell Avenue, Tower 4, 8th Floor, Suite 8401, Tucson, AZ 85721, USA., Fiorelli RKA; Department of General and Specialized Surgery, Gaffrée e Guinle University Hospital, Federal University of the State of Rio de Janeiro (UNIRIO), Rio de Janeiro 20270-004, Brazil., Pereira MG; Faculty of Medicine, University of Brasilia, Federal District, Brasilia 70919-900, Brazil., Lorio MP; Advanced Orthopaedics, 499 E. Central Pkwy, Ste. 130, Altamonte Springs, FL 32701, USA., Burkhardt BW; Wirbelsäulenzentrum/Spine Center-WSC, Hirslanden Klinik Zurich, Witellikerstrasse 40, 8032 Zurich, Switzerland., Oertel JM; Klinik für Neurochirurgie, Universität des Saarlandes, Kirrberger Straße 100, 66421 Homburg, Germany., Winkler PA; Department of Neurosurgery, Charite Universitaetsmedizin Berlin, 13353 Berlin, Germany., Yang H; Orthopaedic Department, The First Affiliated Hospital of Soochow University, No. 899 Pinghai Road, Suzhou 215031, China., León JFR; Minimally Invasive Spine Center Bogotá D.C. Colombia, Reina Sofía Clinic Bogotá D.C. Colombia, Department of Orthopaedics, Fundación Universitaria Sanitas, Bogotá 110141, Colombia., Telfeian AE; Department of Neurosurgery, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, RI 02903, USA., Dowling Á; Department of Orthopaedic Surgery, University of São Paulo, Ribeirão Preto 14071-550, Brazil., Vargas RAA; Department of Neurosurgery, Foundation Hospital Centro Médico Campinas, Campinas 13083-210, Brazil., Ramina R; Neurological Institute of Curitiba, Curitiba 80230-030, Brazil., Asefi M; Department of Biology, Nano-Biology, University of North Carolina, Greensboro, NC 27413, USA., de Carvalho PST; Pain and Spine Minimally Invasive Surgery Service, Gaffre e Guinle University Hospital, Rio de Janeiro 20270-004, Brazil., Defino H; Department of Orthopaedic Surgery, University of São Paulo, Ribeirão Preto 14071-550, Brazil., Moyano J; La Sociedad Iberolatinoamericana De Columna (SILACO), The Spine Committee of the Ecuadorian Society of Orthopaedics and Traumatology (Comité de Columna de la Sociedad Ecuatoriana de Ortopedia y Traumatología), Quito 170521, Ecuador., Montemurro N; Department of Neurosurgery, Azienda Ospedaliero Universitaria Pisana, University of Pisa, 56124 Pisa, Italy., Yeung A; Desert Institute for Spine Care, Phoenix, AZ 85020, USA., Novellino P; Guinle and State Institute of Diabetes and Endocrinology, Rio de Janeiro 20270-004, Brazil., On Behalf Of Teams/Organizations/Institutions
Jazyk:	angličtina
Zdroj:	Journal of personalized medicine [J Pers Med] 2023 Jun 25; Vol. 13 (7). Date of Electronic Publication: 2023 Jun 25.
DOI:	10.3390/jpm13071044
Abstrakt:	Proving clinical superiority of personalized care models in interventional and surgical pain management is challenging. The apparent difficulties may arise from the inability to standardize complex surgical procedures that often involve multiple steps. Ensuring the surgery is performed the same way every time is nearly impossible. Confounding factors, such as the variability of the patient population and selection bias regarding comorbidities and anatomical variations are also difficult to control for. Small sample sizes in study groups comparing iterations of a surgical protocol may amplify bias. It is essentially impossible to conceal the surgical treatment from the surgeon and the operating team. Restrictive inclusion and exclusion criteria may distort the study population to no longer reflect patients seen in daily practice. Hindsight bias is introduced by the inability to effectively blind patient group allocation, which affects clinical result interpretation, particularly if the outcome is already known to the investigators when the outcome analysis is performed (often a long time after the intervention). Randomization is equally problematic, as many patients want to avoid being randomly assigned to a study group, particularly if they perceive their surgeon to be unsure of which treatment will likely render the best clinical outcome for them. Ethical concerns may also exist if the study involves additional and unnecessary risks. Lastly, surgical trials are costly, especially if the tested interventions are complex and require long-term follow-up to assess their benefit. Traditional clinical testing of personalized surgical pain management treatments may be more challenging because individualized solutions tailored to each patient's pain generator can vary extensively. However, high-grade evidence is needed to prompt a protocol change and break with traditional image-based criteria for treatment. In this article, the authors review issues in surgical trials and offer practical solutions.
Databáze:	MEDLINE
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