Response to Saiz et al., “Misreporting of a Plasma Rich in Growth Factors Trial on Knee Osteoarthritis”

This letter is a response to the letter by Saiz et al. that argued misreporting in the publication by Sanchez et al.1Sánchez M. Fiz N. Azofra J. et al.A randomized clinical trial evaluating plasma rich in growth factors (PRGF-Endoret) versus hyaluronic acid in the short-term treatment of symptomatic knee osteoarthritis.Arthroscopy. 2012; 28: 1070-1078Abstract Full Text Full Text PDF PubMed Scopus (247) Google Scholar Recently, we have been requested by Saiz et al. to provide certain documentation linked to the clinical trial and the publication mentioned above. We fully complied with this request, sending the documents of the study protocol, ethics committee approval, and brief final report. Saiz et al. have published a “Call to Action: RIAT Restoration of a Misreported Clinical Trial on Plasma Rich in Growth Factors”2Saiz L.C. Erviti J. Leache L. Call to action: RIAT restoration of a misreported clinical trial on plasma rich in growth factors.https://www.bmj.com/content/346/bmj.f2865/rr-11Google Scholar online as a quick response (https://www.bmj.com/content/346/bmj.f2865/rr-11) to settle existing discrepancies between the final protocol of the trial and the publication in Arthroscopy. To be honest, we were surprised about several issues: (a) the fast publication of the “Call to Action”; (b) the way these potential discrepancies were interpreted by Saiz et al.; (c) the whole procedure removed from the present by almost a decade, with many of the scientists and clinicians involved in the trial now distant from the project and their previous responsibilities. This said, we have actively participated in this process by sending the requested documents and by contacting the Ethics Committee that handled the trial protocol. This has urged us to seek the opinion of the Ethics Committee that approved, reviewed, and followed all the phases of study progress until the final publication of the results in Arthroscopy. By law, the Ethics Committee is the highest independent and impartial part that has all the documents related to a study. The Ethics Committee, after reviewing their records, emitted a communication in which their conformity and agreement with the methodology, the revision of the outcome endpoint, and the publication has been clearly indicated. They have found no ethical problems. We have informed and sent a copy of this communication by the Ethics Committee to Saiz et al. Once the study finished, and understanding that the percentage of pain that patients present cannot be assigned an exact numerical value, we considered exploring several percentages of pain improvement (as the main variable) for two reasons: the study protocol and the recommendations of Osteoarthritis Research Society International (OARSI) when assessing the response to treatment in patients diagnosed with osteoarthritis of the knee. According to the first point, we prepared a preliminary report that we sent to the Ethics Committee with the improvement results >40%. This report was also sent to Saiz et al. and is the one that has supported the basis for his discrepancy with the data published in Arthroscopy. However, we sent the final report of the clinical trial to the Ethics Committee taking into account the OARSI considerations, that is, the number of patients who achieve a percentage of improvement ≥50% in the study variables and which we understood suited well with the range or framework of the study protocol. At all times, the Ethics Committee was notified and endorsed this final report, which is the one that corresponds faithfully to the publication in the journal. We are convinced that the error in interpreting and correlating the clinical trial reports (preliminary and final) with the scientific article is what has led us to this position. Our idea has always been to transparently report the results of the clinical trial. In fact, in the publication we even reported results at 20% improvement, with no statistically significant differences. The use of plasma rich in growth factors (PRGF) as a treatment for knee osteoarthritis has been explored in many clinical studies, apart from the one mentioned above. In fact, while our clinical trial was underway and before the results were obtained, another research group in Madrid contacted us to obtain information about the trial, the methodology, and the assessment variables, as they aimed to conduct a new clinical trial. The principal investigator of the trial, Dr. Víctor Vaquerizo, decided, based on the information provided, to use as a final variable the number of patients who achieve a percentage of improvement ≥50% in the study variables. As stated in that manuscript, published in Arthroscopy by Vaquerizo et al., “The primary outcome measures were 30% and 50% decrease in the total score for the pain, physical function, and stiffness subscales of the Osteoarthritis Index of the Universities of Western Ontario and McMaster (WOMAC) and the Lequesne scores from the start until the 24th and 48th week.”3Vaquerizo V. Plasencia M.Á. Arribas I. et al.Comparison of intra-articular injections of plasma rich in growth factors (PRGF-Endoret) versus Durolane hyaluronic acid in the treatment of patients with symptomatic osteoarthritis: A randomized controlled trial.Arthroscopy. 2013; 29: 1635-1643Abstract Full Text Full Text PDF PubMed Scopus (147) Google Scholar The results of this second clinical trial and other clinical studies support and confirm those obtained in our clinical trial.3Vaquerizo V. Plasencia M.Á. Arribas I. et al.Comparison of intra-articular injections of plasma rich in growth factors (PRGF-Endoret) versus Durolane hyaluronic acid in the treatment of patients with symptomatic osteoarthritis: A randomized controlled trial.Arthroscopy. 2013; 29: 1635-1643Abstract Full Text Full Text PDF PubMed Scopus (147) Google Scholar, 4Say F. Gürler D. Yener K. et al.Platelet-rich plasma injection is more effective than hyaluronic acid in the treatment of knee osteoarthritis.Acta Chir Orthop Traumatol Cech. 2013; 80: 278-283PubMed Google Scholar, 5Filardo G. Kon E. Pereira Ruiz M.T. et al.Platelet-rich plasma intra-articular injections for cartilage degeneration and osteoarthritis: Single- versus double-spinning approach.Knee Surg Sports Traumatol Arthrosc. 2012; 20: 2082-2091Crossref PubMed Scopus (235) Google Scholar, 6Vaquerizo V. Padilla S. Aguirre J.J. et al.Two cycles of plasma rich in growth factors (PRGF-Endoret) intra-articular injections improve stiffness and activities of daily living but not pain compared to one cycle on patients with symptomatic knee osteoarthritis.Knee Surg Sports Traumatol Arthrosc. 2018; 26: 2615-2621Crossref PubMed Scopus (6) Google Scholar In summary, we have actively collaborated with Saiz et al. since the beginning of this process. The public Ethics Committee was informed with two reports and the final publication in Arthroscopy and has validated and endorsed our ethical approach and behavior, as well as the way the manuscript was prepared. Editors' Note:The Editors very much appreciate the letter from Drs. Saiz and colleagues and the reply by Drs. Sanchez et al. We have done our best to investigate and adjudicate the situation. We are unable to confirm definitive evidence of unethical outcome measure manipulation, malicious or otherwise. Time has passed, some of the primary documents are in Spanish, and in the end, there are two sides to the debate. After consultation with an editor of an independent, high-impact orthopaedic subspecialty journal, communication with AANA and Journal Board of Trustees leadership, and careful review of the International Committee of Medical Journal Editors (ICMJE) Recommendations and Committee on Publication Ethics (COPE) Guidance, our decision is to not retract the initial publication. Rather, we have invited and published the Letter to the Editor from Saiz et al. and the Authors’ Reply by Sanchez et al. to bring transparency to the issue. The published letters will refer to the original article, online and in perpetuity.James H. Lubowitz, M.D., Editor-in-ChiefJefferson C. Brand, M.D., Assistant Editor-in-ChiefMichael J. Rossi, M.D., M.S., Assistant Editor-in-Chief The Editors very much appreciate the letter from Drs. Saiz and colleagues and the reply by Drs. Sanchez et al. We have done our best to investigate and adjudicate the situation. We are unable to confirm definitive evidence of unethical outcome measure manipulation, malicious or otherwise. Time has passed, some of the primary documents are in Spanish, and in the end, there are two sides to the debate. After consultation with an editor of an independent, high-impact orthopaedic subspecialty journal, communication with AANA and Journal Board of Trustees leadership, and careful review of the International Committee of Medical Journal Editors (ICMJE) Recommendations and Committee on Publication Ethics (COPE) Guidance, our decision is to not retract the initial publication. Rather, we have invited and published the Letter to the Editor from Saiz et al. and the Authors’ Reply by Sanchez et al. to bring transparency to the issue. The published letters will refer to the original article, online and in perpetuity.James H. Lubowitz, M.D., Editor-in-ChiefJefferson C. Brand, M.D., Assistant Editor-in-ChiefMichael J. Rossi, M.D., M.S., Assistant Editor-in-Chief Download .pdf (7.71 MB) Help with pdf files ICMJE author disclosure forms Misreporting of a Plasma-Rich-in-Growth-Factors Trial on Knee OsteoarthritisArthroscopyVol. 36Issue 3PreviewAs attentive readers of your prestigious journal, we are deeply concerned by a potentially serious case of misreporting affecting Arthroscopy. Early in 2019, our publicly funded research team was commissioned to assess the evidence on platelet-rich plasma and analogues in traumatology. We retrieved, among the appraised publications, the high-impact article published by Sánchez et al.1 evaluating plasma rich in growth factors versus hyaluronic acid for knee osteoarthritis. We asked the authors for additional information, namely the protocol, clinical study report (or similar final report), and ethics committee approval. Full-Text PDF

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