Tag Archive | transparency

Stemming the Tide of Stem Cell Hype

Stem Cells for OBuzzThis post comes from Fred Nelson, MD, an orthopaedic surgeon in the Department of Orthopedics at Henry Ford Hospital and a clinical associate professor at Wayne State Medical School. Some of Dr. Nelson’s tips go out weekly to more than 3,000 members of the Orthopaedic Research Society (ORS), and all are distributed to more than 30 orthopaedic residency programs. Those not sent to the ORS are periodically reposted in OrthoBuzz with the permission of Dr. Nelson.

Despite the absence of research-based guidance, the use of stem cell therapies in musculoskeletal medicine has gained popularity and stimulated patient interest. Consequently, an international consensus was  recently established to develop strategies to improve standardization and transparency when describing cell therapies, and to develop a consensus on the contents of a standardized tool for describing cell therapies.1 The tool, dubbed DOSES, was an outgrowth of a call for improvement in communicating about cell-based therapies made during the American Academy of Orthopaedic Surgeons/National Institutes of Health Optimizing Clinical Use of Biologics Symposium in 2018.

The international experts used an iterative Delphi methodology to develop DOSES. The five components of the DOSES tool are Donor (i.e., autologous, allogeneic, xenogeneic), Origin of tissue (fat, bone marrow, etc.), Separation from other cell types/preparation method, Exhibited cell characteristics, and the Site of delivery. The tool should help clinicians, researchers, regulators, and industry professionals describe and communicate about any given stem cell treatment clearly and transparently.

In a commentary on the DOSES article, Scott Rodeo, MD notes that efforts are under way to clarify and classify stem cells by genomics, proteomics, metabolomics, and other approaches.2 Dr. Rodeo believes that the most important component of DOSES is the “E” category, information that will ultimately characterize the biologic activity of the cell preparation. He concludes by encouraging “clinicians, industry, and authors of both laboratory and clinical studies to begin the use of the DOSES tool, and possibly other algorithms, when communicating the results of cell therapy investigations.” This admonition carries over to journal editors, who, Dr. Rodeo says, should “consider adopting such reporting standards as mandatory for publication” of stem cell studies.

For stem cell therapy to progress clinically in the future, researchers and clinicians must apply a consistent nomenclature to describe cell therapies and actual cell formulations.3 This is lacking in today’s applications.

References

  1. Murray IR, Chahla J, Safran MR, Krych AJ, Saris DBF, Caplan AI, LaPrade RF. International Expert Consensus on a Cell Therapy Communication Tool: DOSES. J Bone Joint Surg Am. 2019 May 15;101(10):904-911. doi: 10.2106/JBJS.18.00915. PMID: 31094982
  2. Rodeo SA. A Call for Standardization in Cell Therapy Studies: Commentary on an article by Iain R. Murray, BMedSci(Hons), MRCS, MFSEM, PhD, et al.: “International Expert Consensus on a Cell Therapy Communication Tool: DOSES”. J Bone Joint Surg Am. 2019 May 15;101(10):e47. doi: 10.2106/JBJS.19.00189. PMID: 31094994.
  3. Jones IA, Chen X, Evseenko D, Vangsness CT Jr. Nomenclature Inconsistency and Selective Outcome Reporting Hinder Understanding of Stem Cell Therapy for the Knee. J Bone Joint Surg Am. 2019 Jan 16;101(2):186-195. doi: 10.2106/JBJS.17.01474. PMID: 30653050

JBJS Editor’s Choice—Patient Price Sensitivity Is Real: Time for Providers to Engage

swiontkowski marc colorThe September 16, 2015 JBJS study by Robinson et al. offers clear proof that many of our patients are sensitive to price when it comes to choosing where to go for arthroscopic surgery of the knee or shoulder. This phenomenon began at least a decade ago when employers began shifting the cost burden of health care coverage onto their employees. The findings from Robinson et al. confirm the increasing strength of this effect.

The authors analyzed administrative data from the California Public Employees’ Retirement System (CalPERS) to evaluate the impact of so-called “reference-based benefits” on patient choice for the setting of arthroscopy—hospital-based outpatient departments or freestanding ambulatory surgery centers (ASCs). Reference-based benefits require patients to pay the cost differential between an insurer-established “contribution limit” and the actual price charged by a facility.

Within two years of shifting to reference-based benefits, CalPERS-covered patients increased their utilization of ASCs by 14.3% for knee arthroscopy and by 9.9% for shoulder arthroscopy, with corresponding decreases in the use of hospital-based facilities. Meanwhile, CalPERS reduced overall spending on these procedures by 13%, and there were no significant before-and-after differences in 90-day complication rates.

These findings lead one to ask what added benefits patients receive from hospital-based outpatient surgery — Is it a safer environment or more convenient? Are the results more predictable?  I think not, and on that basis the added charges are not justified.

Now that Robinson et al. have provided us with hard data on the impact of surgical-setting charges on patient behavior, we need to think about providing additional information that our patients would find helpful. We should, for example, move forward with increasing transparency on surgery fees and charges for outpatient visits, imaging, and durable medical goods. The time is right for us to do our part in eliminating this “black box” aspect of orthopaedic care.

At the same time, as commentators Kern Singh and Junyoung Ahn note, because payers will continue to define value according to their criteria, “orthopaedic surgeons should increase their involvement in this process to ensure the balance between outcome benefits and associated costs.”

Marc Swiontkowski, MD

JBJS Editor-in-Chief