| 1. |
Polascik BA, Peck J, Cepeda N, Lyman S, Ling D. , Reporting Clinical Significance in Hip Arthroscopy: Where Are We Now? , HSS Journal, 10.1007/s11420-020-09759-3, 2020.12, Background: Although p values are standard for reporting statistical significance of patient-reported outcome measures (PROMs), the shift toward clinically important outcome values, including minimal clinically important difference (MCID) and substantial clinical benefit (SCB), necessitates re-evaluation of the current literature.
Questions/purposes: We sought to answer two questions regarding studies on primary hip arthroscopy performed for the treatment of femoroacetabular impingement syndrome (FAIs). (1) Do such studies reporting statistical significance on common PROMs meet published MCID/SCB thresholds? (2) What proportion of such studies report both statistical and clinical significance?
Methods: We identified four papers published in two journals defining MCID/SCB values on the modified Harris Hip Score (mHHS), Hip Outcome Score-Activities of Daily Living (HOS-ADL), Hip Outcome Score-Sport (HOS-Sport), international Hip Outcome Tool (iHOT-33), and its short version (iHOT-12) for different groups of FAIS patients undergoing hip arthroscopy. We reviewed these two journals from the dates of publication to the present to identify papers reporting changes in post-operative PROMs. The difference in pre- and post-operative scores on each PROM was calculated and compared to MCID/SCB thresholds.
Results: Twelve studies were included. Ten studies (83%) evaluated mHHS (90% met MCID, 50% met SCB), seven (58%) evaluated HOS-ADL (100% met MCID/SCB) and HOS-Sport (100% met MCID, 57% met SCB), and one (8%) evaluated iHOT-33 (met MCID/SCB) and iHOT-12 (met MCID). Most studies met MCID and SCB at both 1- and 2-year timepoints. Of the studies evaluated, 50% reported clinical relevance.
Conclusions: Nearly all studies evaluated met MCID, while fewer met SCB. Only half discussed these clinical measures. It is proposed that all future studies report both statistical and clinical significance as standard best practice.
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| 2. |
Goodman SM, Mehta BY, Kahlenberg CA, Krell EC, Nguyen J, Finik J, Figgie MP, Parks ML, Padgett DE, Antao VC, Yates AJ, Springer BD, Lyman SL, Singh JA., Response to Letter to the Editor on "Assessment of a Satisfaction Measure for Use After Primary Total Joint Arthroplasty"., Journal of Arthroplasty, 10.1016/j.arth.2020.07.002., 2020.11, Not available.. |
| 3. |
Fontana MA, Lyman S, Padgett DE, MacLean CH. , Reply to the Letter to the Editor: Can Machine Learning Algorithms Predict Which Patients Will Achieve Minimally Clinically Important Differences From Total Joint Arthroplasty? , Clinical Orthopedics and Related Research, 10.1097/CORR.0000000000001227. , 2020.06, Not available. . |
| 4. |
Lyman S., That's Why They Call It Practice: The Arthroscopic Learning Curve. , Journal of Arthroscopy, 10.1016/j.arthro.2020.02.033. , 2020.05, The learning curve for hip arthroscopy is steep. This progress represented a combination of both increased technical skill and, importantly, development of more refined surgical indications. In the end, safety and efficiency are aspects of a well performed operation, and the ultimate aspect is long-term patient outcome.. |
| 5. |
Leonard Lyman Stephen, The Author Respond, Journal of the American Academy of Orthopaedic Surgeons, 10.5435/JAAOS-D-17-00887, 2018.05. |
| 6. |
Benedict U. Nwachukwu, Cynthia A. Kahlenberg, Jason D. Lehman, Leonard Lyman Stephen, Robert G. Marx, Reply, Orthopedics, 10.3928/01477447-20180109-02, 2018.01. |
| 7. |
Leonard Lyman Stephen, Kaitlyn L. Yin, Patient-reported outcome measurement for patients with total knee arthroplasty, Journal of the American Academy of Orthopaedic Surgeons, 10.5435/JAAOS-D-16-00637, 2017.01, Total knee arthroplasty is a large contributor toMedicare costs. In an effort to lower costs and improve outcomes, the Centers for Medicaid and Medicare Services has implemented theComprehensiveCare for Joint Replacementmodel,which incentivizes surgeons to submit both general health and joint-specific patient-reported outcome measures (PROMs). However, in addition to using PROMs for reporting purposes, surgeons should also consider incorporating PROMs into clinical practice. Currently, PROMs are not widely implemented in the clinical setting despite their value in measuring factors such as patients expectations and mental state, which impact outcomes. Furthermore, as technology improves, PROM collection will become faster and more efficient. The information collected by PROMs can informtreatment decisions and facilitate communication between the surgeon and the patient.. |
| 8. |
William W. Schairer, Benedict U. Nwachukwu, Frank McCormick, Leonard Lyman Stephen, David J. Mayman, Authors’ Reply, Arthroscopy - Journal of Arthroscopic and Related Surgery, 10.1016/j.arthro.2016.05.030, 2016.08. |
| 9. |
Leonard Lyman Stephen, Chisa Hidaka, Patient-Reported Outcome Measures-What Data Do We Really Need?, Journal of Arthroplasty, 10.1016/j.arth.2016.01.073, 2016.06, The Center for Medicaid and Medicare Services has recently announced the inclusion of several patient-reported outcome measures (PROMs), including the abbreviated Hip Disability and Osteoarthritis Outcome Score and Knee Injury and Osteoarthritis Outcome Score for joint replacement (HOOS, JR and KOOS, JR) for the purpose of quality assessment in total hip and total knee replacement (THR and TKR). Historically, Center for Medicaid and Medicare Services and other agencies have used measures of process (eg, % vaccinated) or adverse events (eg, infection rates, readmission rates) for quality assessment. However, the use of PROMs has become a priority based on stated goals by the National Quality Strategy and Institute of Medicine for a more patient-centered approach. Here, we review several general health and joint-specific PROMs, which have been extensively used in research to assess treatment efficacy and discuss their relevance to the new criteria for quality assessment, particularly for THR and TKR. Although we expect HOOS, JR and KOOS, JR to yield much useful information in the near term, these surveys are likely an interim solution. In the future, we anticipate that novel measurement platforms, such as wearable technologies or patient-specific surveys, may open new and exciting avenues of research to discover which types of data-perhaps not previously available-best represent patient quality of life and satisfaction after THR, TKR, or other orthopedic procedures.. |
| 10. |
Ola Rolfson, Kate Eresian Chenok, Eric Bohm, Anne Lübbeke, Geke Denissen, Jennifer Dunn, Leonard Lyman Stephen, Patricia Franklin, Michael Dunbar, Søren Overgaard, Göran Garellick, Jill Dawson, Patient-reported outcome measures in arthroplasty registries
Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries: Part I. Overview and rationale for patient-reported outcome measures, Acta Orthopaedica, 10.1080/17453674.2016.1181815, 2016.06, The International Society of Arthroplasty Registries (ISAR) Steering Committee established the Patient-Reported Outcome Measures (PROMs) Working Group to convene, evaluate, and advise on best practices in the selection, administration, and interpretation of PROMs and to support the adoption and use of PROMs for hip and knee arthroplasty in registries worldwide. The 2 main types of PROMs include generic (general health) PROMs, which provide a measure of general health for any health state, and specific PROMs, which focus on specific symptoms, diseases, organs, body regions, or body functions. The establishment of a PROM instrument requires the fulfillment of methodological standards and rigorous testing to ensure that it is valid, reliable, responsive, and acceptable to the intended population. A survey of the 41 ISAR member registries showed that 8 registries administered a PROMs program that covered all elective hip or knee arthroplasty patients and 6 registries collected PROMs for sample populations; 1 other registry had planned but had not started collection of PROMs. The most common generic instruments used were the EuroQol 5 dimension health outcome survey (EQ-5D) and the Short Form 12 health survey (SF-12) or the similar Veterans RAND 12-item health survey (VR-12). The most common specific PROMs were the Hip disability and Osteoarthritis Outcome Score (HOOS), the Knee injury and Osteoarthritis Outcome Score (KOOS), the Oxford Hip Score (OHS), the Oxford Knee Score (OKS), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the University of California at Los Angeles Activity Score (UCLA).. |
| 11. |
Ola Rolfson, Eric Bohm, Patricia Franklin, Leonard Lyman Stephen, Geke Denissen, Jill Dawson, Jennifer Dunn, Kate Eresian Chenok, Michael Dunbar, Søren Overgaard, Göran Garellick, Anne Lübbeke, Patient-reported outcome measures in arthroplasty registries
Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty RegistriesPart II. Recommendations for selection, administration, and analysis, Acta Orthopaedica, 10.1080/17453674.2016.1181816, 2016.06, — The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain question (“During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?”; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome (“How satisfied are you with your [right/left] [hip/knee] replacement?”; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or missing data.. |
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Leonard Lyman Stephen, Norimasa Nakamura, Brian J. Cole, Christoph Erggelet, Andreas H. Gomoll, Jack Farr, Cartilage-repair innovation at a standstill
Methodologic and regulatory pathways to breaking free, Journal of Bone and Joint Surgery - American Volume, 10.2106/JBJS.15.00573, 2016.01, Articular cartilage defects strongly predispose patients to developing early joint degeneration and osteoarthritis, but for more than 15 years, no new cartilage-repair technologies that we know of have been approved by the U.S. Food and Drug Administration. Many studies examining novel approaches to cartilage repair, including cell, tissue, or matrix-based techniques, have shown great promise, but completing randomized controlled trials (RCTs) to establish safety and efficacy has been challenging, providing a major barrier to bringing these innovations into clinical use. In this article, we review reasons that surgical innovations are not well-suited for testing through RCTs. We also discuss how analytical methods for reducing bias, such as propensity scoring, make prospective observational studies a potentially viable alternative for testing the safety and efficacy of cartilage-repair and other novel therapies, offering the real possibility of therapeutic innovation.. |
| 13. |
Leonard Lyman Stephen, CORR Insights
®
Women Demonstrate More Pain and Worse Function Before THA but Comparable Results 12 Months After Surgery, Clinical orthopaedics and related research, 10.1007/s11999-015-4548-7, 2015.09. |
| 14. |
Leonard Lyman Stephen, CORR Insights
®
Do Claims-based Comorbidities Adequately Capture Case Mix for Surgical Site Infections?, Clinical orthopaedics and related research, 10.1007/s11999-015-4149-5, 2015.05. |
| 15. |
Barton J. Mann, Taco Gosens, Leonard Lyman Stephen, Quantifying clinically significant change
A brief review of methods and presentation of a hybrid approach, American Journal of Sports Medicine, 10.1177/0363546512457346, 2012.10, Treatment outcome researchers in orthopaedics frequently report only tests of statistical significance between group means to evaluate the effectiveness of a given intervention. Although important in establishing that mean differences are not caused by chance, these methods do not reflect the extent to which an intervention produces improvements that are meaningful and represent a return to health. This is an issue that is often of great interest to patients and clinicians. Other methods use a percentage change in an outcome measure (eg, 25% reduction in pain score) to classify treatment responders but often do not indicate whether the treatment restored a patient to normal. Researchers have developed several indices that provide a metric for statistically defining the amount of change that patients consider to be important. In this article, we focus on the concept of "clinical significance" and the different methods that have been developed to define clinically significant change using statistics. We then present a hybrid method that can classify whether a patient has returned to normal function. We apply this method to real patient data to illustrate its use with different outcome instruments commonly used in orthopaedic sports medicine. We advocate that the addition of these methods to reports from clinical outcome studies can deepen our understanding of the impact of interventions on patients' lives.. |
| 16. |
Laurent Audigé, Olufemi R. Ayeni, Mohit Bhandari, Brian Boyle, Karen K. Briggs, Kevin Chan, Kira Chaney-Barclay, Huong T. Do, Mario Ferretti, Freddie H. Fu, Jörg Goldhahn, Sabine Goldhahn, Chisa Hidaka, Amy Hoang-Kim, Jón Karlsson, Aaron J. Krych, Robert F. LaPrade, Bruce A. Levy, James H. Lubowitz, Leonard Lyman Stephen, Yan Ma, Robert G. Marx, Nicholas Mohtadi, Giulio Maria Marcheggiani Muccioli, Norimasa Nakamura, Joseph Nguyen, Gary G. Poehling, Lauren Elizabeth Roberts, Nahum Rosenberg, Kevin P. Shea, Zahra N. Sohani, Michael Soudry, Sophocles Voineskos, Stefano Zaffagnini, ISAKOS scientific committee research methods handbook. A practical guide to research
Design, execution, and publication (Arthroscopy: The Journal of Arthroscopic and Related Surgery), Arthroscopy - Journal of Arthroscopic and Related Surgery, 10.1016/S0749-8063(11)00431-2, 2011.06. |
| 17. |
Scientific Committee ISAKOS Scientific Committee, Laurent Audigé, Olufemi R. Ayeni, Mohit Bhandari, Brian W. Boyle, Karen K. Briggs, Kevin Chan, Kira Chaney-Barclay, Huong T. Do, Mario Ferretti, Freddie H. Fu, Jörg Goldhahn, Sabine Goldhahn, Chisa Hidaka, Amy Hoang-Kim, Jón Karlsson, Aaron J. Krych, Robert F. LaPrade, Bruce A. Levy, James H. Lubowitz, Leonard Lyman Stephen, Yan Ma, Robert G. Marx, Nicholas Mohtadi, Giulio Maria Marcheggiani Muccioli, Norimasa Nakamura, Joseph Nguyen, Gary G. Poehling, Gary G. Poehling, Nahum Rosenberg, Kevin P. Shea, Zahra N. Sohani, Michael Soudry, Sophocles Voineskos, Stefano Zaffagnini, Med International Society of Arthroscopy, Knee Surgery, A practical guide to research
design, execution, and publication., Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association, 10.1016/j.arthro.2011.02.001, 2011.04. |
| 18. |
Leonard Lyman Stephen, Higher hospital volume and specialisation, BMJ (Online), 10.1136/bmj.c160, 2010.02. |
| 19. |
Leonard Lyman Stephen, Robert G. Marx, Peter B. Bach, Cost-effectiveness analysis of an established, effective procedure, Archives of Internal Medicine, 10.1001/archinternmed.2009.144, 2009.06. |
| 20. |
Nigel E. Sharrock, Alejandro Gonzalez Della Valle, George Go, Leonard Lyman Stephen, Eduardo A. Salvati, Reply to letter to editor
Potent anticoagulants are associated with a higher all-cause mortality rate after hip and knee arthroplasty, Clinical orthopaedics and related research, 10.1007/s11999-008-0325-1, 2008.08. |
| 21. |
Keith M. Baumgarten, Stephen Fealy, Leonard Lyman Stephen, Thomas L. Wickiewicz, The coronal plane high tibial osteotomy. Part 1
A clinical and radiographic analysis of intermediate term outcomes, HSS Journal, 10.1007/s11420-007-9050-7, 2007.09, The coronal plane high tibial osteotomy is a novel technique that is used to treat tibiofemoral malalignment. The authors hypothesize that the coronal plane high tibial osteotomy is (1) efficacious in treating both varus and valgus tibiofemoral malalignment; (2) does not alter the slope of the proximal tibia; and (3) does not alter the relationship between the patella and tibial tubercle. A retrospective review of 25 patients with tibiofemoral malalignment (19 varus/6 valgus) treated with a coronal plane osteotomy with a minimum of 2-year follow-up was performed. A Kaplan-Meyer survival curve was performed using knee arthroplasty and a Hospital for Special Surgery (HSS) knee score |
| 22. |
Shane J. Nho, Michael K. Shindle, Seth L. Sherman, Kevin B. Freedman, Leonard Lyman Stephen, John D. MacGillivray, Systematic review of arthroscopic rotator cuff repair and mini-open rotator cuff repair, Journal of Bone and Joint Surgery - Series A, 10.2106/00004623-200710001-00013, 2007.01. |
| 23. |
Warren R. Dunn, Leonard Lyman Stephen, Robert G. Marx, Small area variation in orthopedics., The journal of knee surgery, 2005.01, It is clear that small area variation exists in orthopedics, but there is still much to learn. Given the many unanswered questions regarding area variation, regulatory policy at this time would be premature. The biggest piece of the puzzle that needs to be solved is the influence of disease prevalence and severity. While it seems unlikely this will explain all of the variation, it is equally unlikely that musculoskeletal diseases are distributed evenly across geopolitical boundaries, hence, it likely accounts for some of the observed variation. More patient-level studies need to be conducted in non-Medicare populations. For example, the extent to which area variation exists in sports medicine and knee surgery for younger patients is unknown. Profiling is likely here to stay. In accord, it should be exploited by the orthopedic community for its strengths while keeping in mind its limitations. Orthopedic surgeons should be at the forefront of this research and consequently influential in its evolution rather than have the managed care industry or government dictate policy.. |
| 24. |
Warren R. Dunn, Leonard Lyman Stephen, Robert Marx, Research methodology, Arthroscopy - Journal of Arthroscopic and Related Surgery, 10.1016/S0749-8063(03)00705-9, 2003.01, Research aims to reach valid conclusions through scientific enquiry. Valid conclusions can only be reached if bias is minimized or eliminated. Bias can potentially take place in the design, implementation, or analysis of a study. Various study designs reduce bias, and this article reviews some of the more common study designs in orthopaedic sports medicine. We also discuss bias and confounding factors as they relate to these studies.. |
| 25. |
Leonard Lyman Stephen, Letters to the editor (multiple letters), American Journal of Sports Medicine, 2000.12. |
| 26. |
Leonard Lyman Stephen, The effect of neuromuscular training on the incidence of knee injury in female athletes
a prospective study., American Journal of Sports Medicine, 2000.11. |
