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1. Real-world experience of venetoclax with azacitidine for untreated patients with acute myeloid leukemia

Author

Amanda C. Winters, Jonathan A. Gutman, Enkhtsetseg Purev, Molly Nakic, Jennifer Tobin, Stephanie Chase, Jeff Kaiser, Lindsey Lyle, Chelsey Boggs, Keri Halsema, Jeffrey T. Schowinsky, Julie Rosser, Mark D. Ewalt, Bradford Siegele, Vishal Rana, Steven Schuster, Diana Abbott, Brett M. Stevens, Craig T. Jordan, Clayton Smith, and Daniel A. Pollyea

Subjects
Specialties of internal medicine, RC581-951
Abstract

Abstract: Venetoclax is approved for older untreated acute myeloid leukemia (AML) patients. Venetoclax was available prior to approval off-label. We assessed our single-institution off-label experience with venetoclax/azacitidine, comparing outcomes with a clinical trial cohort that administered this regimen at the same institution. Thirty-three untreated AML patients unfit or unwilling to receive induction chemotherapy and prescribed venetoclax/azacitidine off-trial were retrospectively analyzed and compared with 33 patients who received the same therapy on trial. Outcomes were compared, and comparisons were made to a theoretical scenario in which off-trial patients received induction. Digital droplet polymerase chain reaction evaluated measurable residual disease (MRD). Off-trial venetoclax was attainable in nearly all patients for whom this was desired. The complete remission (CR)/CR with incomplete blood count recovery rate was 63.3% for off-trial patients who received treatment and 84.9% for trial patients (P = .081). The median overall survival for off-trial patients who received treatment was 381 days (95% confidence interval [CI], 174, not reached) vs 880 days (95% CI, 384, not reached) for trial patients (P = .041). Prior exposure to hypomethylating agents was associated with worse outcomes. Response rates with venetoclax/azacitidine were not inferior to a theoretical scenario in which patients received induction, and early death rates were less than expected with induction. MRD negativity was achievable. Newly diagnosed AML patients treated in a “real-world” scenario with off-trial venetoclax/azacitidine had inferior outcomes compared with patients treated in the setting of a clinical trial. Additionally, this therapy may be as effective, and less toxic, when compared with induction chemotherapy.

Published
2019
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2. ASH Highlights and Commentary: Myeloid Malignancies

Author

Lindsey Lyle, MS, PA-C

Abstract

This supplement to JADPRO provides an overview of several abstracts that were presented at the 2021 ASH Annual Meeting, along with expert commentary that aims to contextualize the information presented at ASH for the advanced practitioner. Lindsey Lyle, MS, PA-C, of University of Colorado Anschutz Medical Campus, considers promising results in the myeloid malignancies space. Ms. Lyle highlights long-term data on the combination of eprenetapopt (APR-246) and azacitidine in patients with TP53-mutated acute myeloid leukemia/myelodysplastic syndromes, a new option for patients with paroxysmal nocturnal hemoglobinuria, and valuable insights into Black and non-Black patient preferences regarding their treatment and communication with their providers.

Published
2022

3. Real-world experience of venetoclax with azacitidine for untreated patients with acute myeloid leukemia

Author

Brett M. Stevens, Mark D. Ewalt, Diana Abbott, Daniel A. Pollyea, Stephanie Chase, Jennifer Tobin, Molly Nakic, Chelsey Boggs, Jeffrey Schowinsky, Bradford Siegele, Steven R. Schuster, Jonathan A. Gutman, Keri Halsema, Enkhtsetseg Purev, Lindsey Lyle, Jeff Kaiser, Clayton A. Smith, Amanda Winters, Julie Rosser, Craig T. Jordan, and Vishal Rana

Subjects
Male, medicine.medical_specialty, Neoplasm, Residual, Myeloid, Clinical Trials and Observations, Azacitidine, chemistry.chemical_compound, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Humans, Medicine, Genetic Testing, Aged, Aged, 80 and over, Sulfonamides, business.industry, Venetoclax, Remission Induction, Myeloid leukemia, Induction chemotherapy, Hematology, Middle Aged, Bridged Bicyclo Compounds, Heterocyclic, Prognosis, medicine.disease, Clinical trial, Leukemia, Myeloid, Acute, Leukemia, Regimen, Treatment Outcome, medicine.anatomical_structure, chemistry, Female, business, Follow-Up Studies, medicine.drug
Abstract

Venetoclax is approved for older untreated acute myeloid leukemia (AML) patients. Venetoclax was available prior to approval off-label. We assessed our single-institution off-label experience with venetoclax/azacitidine, comparing outcomes with a clinical trial cohort that administered this regimen at the same institution. Thirty-three untreated AML patients unfit or unwilling to receive induction chemotherapy and prescribed venetoclax/azacitidine off-trial were retrospectively analyzed and compared with 33 patients who received the same therapy on trial. Outcomes were compared, and comparisons were made to a theoretical scenario in which off-trial patients received induction. Digital droplet polymerase chain reaction evaluated measurable residual disease (MRD). Off-trial venetoclax was attainable in nearly all patients for whom this was desired. The complete remission (CR)/CR with incomplete blood count recovery rate was 63.3% for off-trial patients who received treatment and 84.9% for trial patients (P = .081). The median overall survival for off-trial patients who received treatment was 381 days (95% confidence interval [CI], 174, not reached) vs 880 days (95% CI, 384, not reached) for trial patients (P = .041). Prior exposure to hypomethylating agents was associated with worse outcomes. Response rates with venetoclax/azacitidine were not inferior to a theoretical scenario in which patients received induction, and early death rates were less than expected with induction. MRD negativity was achievable. Newly diagnosed AML patients treated in a “real-world” scenario with off-trial venetoclax/azacitidine had inferior outcomes compared with patients treated in the setting of a clinical trial. Additionally, this therapy may be as effective, and less toxic, when compared with induction chemotherapy.

Published
2019

7. Human occupation of northern Australia by 65,000 years ago

Author

Chris Clarkson, Tessa Murphy, Jillian Huntley, Richard Fullagar, Helen E. A. Brand, Lynley A. Wallis, Mara Page, Mike Smith, Lee J. Arnold, Xavier Carah, Kasih Norman, James Shulmeister, Kelsey M. Lowe, Tiina Manne, Richard G. Roberts, Ben Marwick, Colin Pardoe, Zenobia Jacobs, S. Anna Florin, Lindsey Lyle, Kate Connell, Gayoung Park, Quan Hua, Delyth Cox, Jessica McNeil, Andrew Fairbairn, Makiah Salinas, and Elspeth Hayes

Subjects
Geologic Sediments, 010506 paleontology, Human Migration, Context (language use), engineering.material, 01 natural sciences, Megafauna, Animals, Humans, Assemblage (archaeology), 0601 history and archaeology, History, Ancient, Neanderthals, 0105 earth and related environmental sciences, Stone tool, Multidisciplinary, 060102 archaeology, biology, Fossils, Human migration, business.industry, Australian megafauna, Australia, 06 humanities and the arts, biology.organism_classification, Homo floresiensis, Archaeology, Diet, Africa, engineering, business, Rock shelter
Abstract

The time of arrival of people in Australia is an unresolved question. It is relevant to debates about when modern humans first dispersed out of Africa and when their descendants incorporated genetic material from Neanderthals, Denisovans and possibly other hominins. Humans have also been implicated in the extinction of Australia’s megafauna. Here we report the results of new excavations conducted at Madjedbebe, a rock shelter in northern Australia. Artefacts in primary depositional context are concentrated in three dense bands, with the stratigraphic integrity of the deposit demonstrated by artefact refits and by optical dating and other analyses of the sediments. Human occupation began around 65,000 years ago, with a distinctive stone tool assemblage including grinding stones, ground ochres, reflective additives and ground-edge hatchet heads. This evidence sets a new minimum age for the arrival of humans in Australia, the dispersal of modern humans out of Africa, and the subsequent interactions of modern humans with Neanderthals and Denisovans. Optical dating of sediments containing stone artefacts newly excavated at Madjedbebe, Australia, indicate that human occupation began around 65,000 years ago, thereby setting a new minimum age for the arrival of people in Australia. When did humans first colonize Australia? The date of the initial landing on the continent that is now associated with cold lager and 'Waltzing Matilda' has been highly controversial. Dates from a site called Madjedbebe in northern Australia had put the presence of modern humans in Australia at between 60,000 and 50,000 years ago, but these results have since been hotly contested. Here, the results from a comprehensive program of dating of new excavations at the site confirm that people first arrived there around 65,000 years ago. The results show that humans reached Australia well before the extinction of the Australian megafauna and the disappearance of Homo floresiensis in neighbouring Indonesia.

Published
2017

9. Iron Overload in Myelodysplastic Syndromes: Pathophysiology, Consequences, Diagnosis, and Treatment

Author

Alex Hirose and Lindsey Lyle

Subjects
Oncology, Ineffective erythropoiesis, medicine.medical_specialty, Anemia, Thalassemia, Population, Review Article, medicine.disease_cause, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, hemic and lymphatic diseases, medicine, education, education.field_of_study, business.industry, Myelodysplastic syndromes, Deferasirox, medicine.disease, Deferoxamine, chemistry, 030220 oncology & carcinogenesis, business, Deferiprone, 030215 immunology, medicine.drug
Abstract

Myelodysplastic syndromes (MDS) are a heterogeneous group of hematologic neoplasms varying in severity affecting one or more lines of hematopoiesis. Ineffective erythropoiesis results in dysregulation of iron metabolism. Most MDS patients have anemia, and some require regular red blood cell transfusions. These transfusions, in addition to factors of the disease itself, can result in iron overload (IO). Retrospective analyses suggest that MDS patients with IO have reduced overall survival and poorer outcomes following allogeneic stem cell transplant vs. those without IO. Iron chelation therapy (ICT; deferoxamine, deferasirox, or deferiprone) has been used to alleviate IO in other transfusion-dependent hematologic conditions (e.g., thalassemia), but its role in MDS has not been firmly established. A growing body of evidence suggests that ICT in MDS patients is an effective means for reducing transfusional IO and may significantly improve outcomes such as survival. The orally administered iron chelator deferasirox has been widely studied in MDS, and available studies have shown it to be generally well tolerated and effective in reducing IO in this population. The pathophysiology and clinical consequences of IO in MDS, as well as current methods for diagnosing and treating IO in these patients, are discussed.

Published
2019

10. Current and emerging therapies for patients with acute myeloid leukemia: a focus on MCL-1 and the CDK9 pathway

Author

Lindsey, Lyle and Naval, Daver

Subjects
Cyclic N-Oxides, Sulfonamides, Triazines, Antineoplastic Combined Chemotherapy Protocols, Indolizines, Humans, Myeloid Cell Leukemia Sequence 1 Protein, Antineoplastic Agents, Pyridinium Compounds, Bridged Bicyclo Compounds, Heterocyclic, Cyclin-Dependent Kinase 9, Leukemia, Myelomonocytic, Acute
Abstract

Acute myeloid leukemia (AML) is an aggressive hematologic malignancy that largely impacts the elderly population. Not all AML patients are candidates for the mainstay induction and consolidation treatment options. In addition, despite available therapies, most patients will eventually relapse on, or be refractory to, standard induction therapy, with limited subsequent choices and poor prognosis. Recently, several new and emerging therapies, with a variety of mechanisms of action, have broadened the treatment landscape in newly diagnosed and relapsed/refractory (R/R) AML, providing patients and healthcare providers with more options and several targeted treatment approaches. Preclinical data indicate that the anti-apoptotic protein myeloid cell leukemia-1 (MCL-1) is important to AML cell survival. Cyclin-dependent kinase 9 (CDK9), a transcriptional activator necessary for the expression of MCL-1, represents a promising target for future AML therapies. A number of CDK9 inhibitors, as well as several direct MCL-1 inhibitors, are currently in clinical or preclinical development. The CDK9 inhibitors alvocidib, atuveciclib, and TG02 have completed phase 1/2 clinical trials, with results available for the alvocidib trial showing improved complete remission rates (70% vs 46%; P = .003) for alvocidib in combination with cytarabine and mitoxantrone, versus cytarabine/daunorubicin, in patients with newly diagnosed AML. In addition, several phase 1 clinical trials with CDK9 inhibitors are currently recruiting for treatment of advanced AML. A phase 1b study is also ongoing to investigate alvocidib in combination with B-cell lymphoma-2 inhibitor venetoclax for R/R AML. Although further research is needed, CDK9 inhibitors represent a promising new approach for the treatment of AML.

Published
2018

12. Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial

Author

Aaron Nauth, Aaron T. Creek, Abby Zellar, Abdel-Rahman Lawendy, Adam Dowrick, Ajay Gupta, Akhil Dadi, Albert van Kampen, Albert Yee, Alexander C. de Vries, Alexander de Mol van Otterloo, Alisha Garibaldi, Allen Liew, Allison W. McIntyre, Amal Shankar Prasad, Amanda W. Romero, Amar Rangan, Amber Oatt, Amir Sanghavi, Amy L. Foley, Anders Karlsten, Andrea Dolenc, Andrew Bucknill, Andrew Chia, Andrew Evans, Andrew Gong, Andrew H. Schmidt, Andrew J. Marcantonio, Andrew Jennings, Angela Ward, Angshuman Khanna, Anil Rai, Anke B. Smits, Annamarie D. Horan, Anne Christine Brekke, Annette Flynn, Aravin Duraikannan, Are Stødle, Arie B. van Vugt, Arlene Luther, Arthur W. Zurcher, Arvind Jain, Asgeir Amundsen, Ash Moaveni, Ashley Carr, Ateet Sharma, Austin D. Hill, Axel Trommer, B. Sachidananda Rai, Barbara Hileman, Bart Schreurs, Bart Verhoeven, Benjamin B. Barden, Bernhard Flatøy, Berry I. Cleffken, Berthe Bøe, Bertrand Perey, Birgit C. Hanusch, Brad Weening, Bram Fioole, Bram Rijbroek, Brett D. Crist, Brett Halliday, Brett Peterson, Brian Mullis, C. Glen Richardson, Callum Clark, Carlos A. Sagebien, Carmen C. van der Pol, Carol Bowler, Catherine A. Humphrey, Catherine Coady, Cees L. Koppert, Chad Coles, Chadi Tannoury, Charles J. DePaolo, Chris Gayton, Chris Herriott, Christina Reeves, Christina Tieszer, Christine Dobb, Christopher G. Anderson, Claire Sage, Claudine Cuento, Clifford B. Jones, Coks H.R. Bosman, Colleen Linehan, Cor P. van der Hart, Corey Henderson, Courtland G. Lewis, Craig A. Davis, Craig Donohue, Cyril Mauffrey, D.C. Sundaresh, Dana J. Farrell, Daniel B. Whelan, Daniel Horwitz, Daniel Stinner, Darius Viskontas, Darren M. Roffey, David Alexander, David E. Karges, David Hak, David Johnston, David Love, David M. Wright, David P. Zamorano, David R. Goetz, David Sanders, David Stephen, David Yen, Davide Bardana, Davy J Olakkengil, Deanna Lawson, Deborah Maddock, Debra L. Sietsema, Deeba Pourmand, Dennis Den Hartog, Derek Donegan, Diane Heels-Ansdell, Diane Nam, Dominic Inman, Dory Boyer, Doug Li, Douglas Gibula, Dustin M. Price, Dylan J. Watson, E. Mark Hammerberg, Edward T.C.H. Tan, Eelco J.R. de Graaf, Elise Berg Vesterhus, Elizabeth Roper, Elton Edwards, Emil H. Schemitsch, Eric R. Hammacher, Eric R. Henderson, Erica Whatley, Erick T. Torres, Erik G.J. Vermeulen, Erin Finn, Esther M.M. Van Lieshout, Eugene K. Wai, Evan R. Bannister, Evelyn Kile, Evert B.M. Theunissen, Ewan D. Ritchie, Farah Khan, Farhad Moola, Fiona Howells, Frank de Nies, Frank H.W.M. van der Heijden, Frank R.A.J. de Meulemeester, Frede Frihagen, Fredrik Nilsen, G. Ben Schmidt, G.H. Robert Albers, Garland K. Gudger, Garth Johnson, Gary Gruen, Gary Zohman, Gaurav Sharma, Gavin Wood, Geert W.M. Tetteroo, Geir Hjorthaug, Geir Jomaas, Geoff Donald, Geoffrey Ryan Rieser, Gerald Reardon, Gerard P. Slobogean, Gert R Roukema, Gijs A. Visser, Gilbert Moatshe, Gillian Horner, Glynis Rose, Gordon Guyatt, Graham Chuter, Greg Etherington, Gregory J. Della Rocca, Guri Ekås, Gwendolyn Dobbin, H. Michael Lemke, Hamish Curry, Han Boxma, Hannah Gissel, Hans Kreder, Hans Kuiken, Hans L.F. Brom, Hans-Christoph Pape, Harm M van der Vis, Harvinder Bedi, Heather A. Vallier, Heather Brien, Heather Silva, Heike Newman, Helena Viveiros, Henk van der Hoeven, Henry Ahn, Herman Johal, Herman Rijna, Heyn Stockmann, Hong A. Josaputra, Hope Carlisle, Igor van der Brand, Imro Dawson, Ivan Tarkin, Ivan Wong, J. Andrew Parr, J. Andrew Trenholm, J. Carel Goslings, J. David Amirault, J. Scott Broderick, Jaap P. Snellen, Jacco A.C. Zijl, Jaimo Ahn, James Ficke, James Irrgang, James Powell, James R. Ringler, James Shaer, James T. Monica, Jan Biert, Jan Bosma, Jan Egil Brattgjerd, Jan Paul M. Frölke, Jan Wille, Janakiraman Rajakumar, Jane E. Walker, Janell K. Baker, Janos P. Ertl, Jean Paul P.M. de Vries, Jean W.M. Gardeniers, Jedediah May, Jeff Yach, Jennifer T. Hidy, Jerald R. Westberg, Jeremy A. Hall, Jeroen van Mulken, Jessica Cooper McBeth, Jochem Hoogendoorn, Jodi M. Hoffman, Joe Joseph Cherian, John A. Tanksley, John Clarke-Jenssen, John D. Adams, John Esterhai, John F. Tilzey, John Murnaghan, John P. Ketz, John S. Garfi, John Schwappach, John T. Gorczyca, John Wyrick, Jonas Rydinge, Jonathan L. Foret, Jonathan M. Gross, Jonathan P. Keeve, Joost Meijer, Joris J.G. Scheepers, Joseph Baele, Joseph O'Neil, Joseph R. Cass, Joseph R. Hsu, Jules Dumais, Julia Lee, Julie A. Switzer, Julie Agel, Justin E. Richards, Justin W. Langan, Kahn Turckan, Kaili Pecorella, Kamal Rai, Kamran Aurang, Karl Shively, Karlijn van Wessem, Karyn Moon, Kate Eke, Katie Erwin, Katrine Milner, Kees Jan Ponsen, Kelli Mills, Kelly Apostle, Kelly Johnston, Kelly Trask, Kent Strohecker, Kenya Stringfellow, Kevin K. Kruse, Kevin Tetsworth, Khalis Mitchell, Kieran Browner, Kim Hemlock, Kimberly Carcary, Knut Jørgen Haug, Krista Noble, Kristin Robbins, Krystal Payton, Kyle J. Jeray, L. Joseph Rubino, Lauren A. Nastoff, Lauren C. Leffler, Laurents P.S. Stassen, Lawrence K. O'Malley, Lawrence M. Specht, Lehana Thabane, Leo M.G. Geeraedts, Leslie E. Shell, Linda K. Anderson, Linda S. Eickhoff, Lindsey Lyle, Lindsey Pilling, Lisa Buckingham, Lisa K. Cannada, Lisa M. Wild, Liz Dulaney-Cripe, Lodewijk M.S.J. Poelhekke, Lonneke Govaert, Lu Ton, Lucksy Kottam, Luke P.H. Leenen, Lydia Clipper, Lyle T. Jackson, Lynne Hampton, Maarten C. de Waal Malefijt, Maarten P. Simons, Maarten van der Elst, Maarten W.G.A. Bronkhorst, Mahesh Bhatia, Marc Swiontkowski, Margaret J. Lobo, Marilyn Swinton, Marinis Pirpiris, Marius Molund, Mark Gichuru, Mark Glazebrook, Mark Harrison, Mark Jenkins, Mark MacLeod, Mark R. de Vries, Mark S. Butler, Markku Nousiainen, Martijne van 't Riet, Martin C. Tynan, Martin Campo, Martin G. Eversdijk, Martin J. Heetveld, Martin Richardson, Mary Breslin, Mary Fan, Matt Edison, Matthew Napierala, Matthias Knobe, Matthias Russ, Mauri Zomar, Maurits de Brauw, Max Esser, Meghan Hurley, Melissa E. Peters, Melissa Lorenzo, Mengnai Li, Michael Archdeacon, Michael Biddulph, Michael Charlton, Michael D. McDonald, Michael D. McKee, Michael Dunbar, Michael E. Torchia, Michael Gross, Michael Hewitt, Michael Holt, Michael J. Prayson, Michael J.R. Edwards, Michael L. Beckish, Michael L. Brennan, Michael P. Dohm, Michael S.H. Kain, Michelle Vogt, Michelle Yu, Michiel H.J. Verhofstad, Michiel J.M. Segers, Michiel P.C. Siroen, Mike Reed, Milena R. Vicente, Milko M.M. Bruijninckx, Mittal Trivedi, Mohit Bhandari, Molly M. Moore, Monica Kunz, Morten Smedsrud, Naveen Palla, Neeraj Jain, Nico J.M. Out, Nicole Simunovic, Niels W.L. Schep, Oliver Müller, Onno R. Guicherit, Oscar J.F. Van Waes, Otis Wang, Pascal G. Doornebosch, Patricia Seuffert, Patrick J. Hesketh, Patrick Weinrauch, Paul Duffy, Paul Keller, Paul M. Lafferty, Paul Pincus, Paul Tornetta, Paul Zalzal, Paula McKay, Peter A. Cole, Peter D. de Rooij, Peter Hull, Peter M.N.Y.M. Go, Peter Patka, Peter Siska, Peter Weingarten, Philip Kregor, Philip Stahel, Philip Stull, Philippe Wittich, Piet A.R. de Rijcke, Pim Oprel, PJ Devereaux, Qi Zhou, R. Lee Murphy, Rachel Alosky, Rachel Clarkson, Raely Moon, Rajanikanth Logishetty, Rajesh Nanda, Raymond J. Sullivan, Rebecca G. Snider, Richard E. Buckley, Richard Iorio, Richard J Farrugia, Richard Jenkinson, Richard Laughlin, Richard P.R. Groenendijk, Richard W. Gurich, Ripley Worman, Rob Silvis, Robert Haverlag, Robert J. Teasdall, Robert Korley, Robert McCormack, Robert Probe, Robert V. Cantu, Roger B. Huff, Rogier K.J. Simmermacher, Rolf Peters, Roman Pfeifer, Ronald Liem, Ronald N. Wessel, Ronald Verhagen, Ronald Vuylsteke, Ross Leighton, Ross McKercher, Rudolf W. Poolman, Russell Miller, Ryan Bicknell, Ryan Finnan, Ryan M. Khan, Samir Mehta, Sandy Vang, Sanjay Singh, Sanjeev Anand, Sarah A. Anderson, Sarah A. Dawson, Scott B. Marston, Scott E. Porter, Scott T. Watson, Sebastiaan Festen, Shane Lieberman, Shannon Puloski, Shea A. Bielby, Sheila Sprague, Shelley Hess, Shelley MacDonald, Simone Evans, Sofia Bzovsky, Sondre Hasselund, Sophie Lewis, Stein Ugland, Stephanie Caminiti, Stephanie L. Tanner, Stephanie M. Zielinski, Stephanie Shepard, Stephen A. Sems, Stephen D. Walter, Stephen Doig, Stephen H. Finley, Stephen Kates, Stephen Lindenbaum, Stephen P. Kingwell, Steve Csongvay, Steve Papp, Steven E. Buijk, Steven J. Rhemrev, Steven M. Hollenbeck, Steven M. van Gaalen, Steven Yang, Stuart Weinerman, null Subash, Sue Lambert, Susan Liew, Sven A.G. Meylaerts, Taco J. Blokhuis, Tammo S. de Vries Reilingh, Tarjei Lona, Taryn Scott, Teresa K. Swenson, Terrence J. Endres, Terry Axelrod, Teun van Egmond, Thomas B. Pace, Thomas Kibsgård, Thomas M. Schaller, Thuan V. Ly, Timothy J. Miller, Timothy Weber, Toan Le, Todd M. Oliver, Tom M. Karsten, Tor Borch, Tor Magne Hoseth, Tor Nicolaisen, Torben Ianssen, Tori Rutherford, Tracy Nanney, Trevor Gervais, Trevor Stone, Tyson Schrickel, Tyson Scrabeck, Utsav Ganguly, V. Naumetz, Valda Frizzell, Veronica Wadey, Vicki Jones, Victoria Avram, Vimlesh Mishra, Vineet Yadav, Vinod Arora, Vivek Tyagi, Vivian Borsella, W. Jaap Willems, W.H. Hoffman, Wade T. Gofton, Wesley G. Lackey, Wesley Ghent, William Obremskey, William Oxner, William W. Cross, Yvonne M. Murtha, Zoe Murdoch, and Surgery

Subjects
Male, Bone Screws, Avascular necrosis, Kaplan-Meier Estimate, law.invention, Fracture Fixation, Internal, 0302 clinical medicine, Randomized controlled trial, Femur Head Necrosis, law, Fracture Fixation, Fracture fixation, Medicine and Health Sciences, 80 and over, Single-Blind Method, 030212 general & internal medicine, Non-U.S. Gov't, Aged, 80 and over, Fracture Healing, 030222 orthopedics, Hip fracture, Research Support, Non-U.S. Gov't, Hazard ratio, General Medicine, Equipment Design, Femur Head Necrosis/etiology, 3. Good health, Pulmonary embolism, Multicenter Study, Treatment Outcome, Randomized Controlled Trial, Fracture Fixation, Internal/adverse effects, Female, Reoperation, musculoskeletal diseases, medicine.medical_specialty, Femoral Neck Fractures/surgery, Internal/adverse effects, Bone healing, Research Support, N.I.H, 03 medical and health sciences, Research Support, N.I.H., Extramural, medicine, Journal Article, Humans, Adverse effect, Aged, business.industry, Extramural, medicine.disease, Femoral Neck Fractures, Surgery, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], Reoperation/statistics & numerical data, Quality of Life, business
Abstract

© 2017 Elsevier Ltd Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. Findings Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0·83, 95% CI 0·63–1·09; p=0·18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1·91, 1·06–3·44; p=0·0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0·82; appendix); these events included pulmonary embolism (two patients [

Published
2017

13. Venetoclax and Azacitidine for Older Newly Diagnosed Patients with Acute Myeloid Leukemia: A Single-Institution Pilot Study Using Measurable Residual Disease to Guide Therapy

Author

Chelsey Boggs, Enkhtsetseg Purev, Jeffrey Schowinsky, Sarah Wright, Dwight Macero, Jonathan A. Gutman, Craig T. Jordan, Angie Falco, Brett M. Stevens, Amanda Winters, Shirstine Rahkola, Natalie Monson, Daniel A. Pollyea, Molly Nakic, Keri Halsema, Shanshan Pei, Diana Abbott, Clayton A. Smith, Andrew Hammes, Alex Hirose, Lindsey Lyle, and Tyler J. D’Ovidio

Subjects
medicine.medical_specialty, Leukopenia, Intention-to-treat analysis, business.industry, Venetoclax, Immunology, Azacitidine, Myeloid leukemia, Cell Biology, Hematology, Neutropenia, medicine.disease, Biochemistry, chemistry.chemical_compound, chemistry, Internal medicine, medicine, medicine.symptom, business, Adverse effect, Febrile neutropenia, medicine.drug
Abstract

Background: Venetoclax (ven) was approved for older untreated acute myeloid leukemia (AML) patients due to high response rates and durable remissions. As a participating site in the dose escalation study, we observed deeper/more durable responses in some who received >400mg ven. We also noted 16/33 discontinued azacitidine (aza) after achieving a response; 9 relapsed and 7 remained in long term remission on ven only. Based on these observations, we designed a study that hypothesized: A)Higher initial doses of ven would allow deeper/more durable responses, and B)Multi modality high sensitivity measurable residual disease (MRD) testing could identify patients able to discontinue aza and remain on maintenance ven. Methods: This is an ongoing phase 2 study (NCT03466294) of 42 untreated AML patients ≥60 who decline/are ineligible for induction. Patients have adequate organ function and white blood cell counts Results: 30 patients enrolled between May 2018 and July 2019; median age is 71 (60-88), 10% evolved from MDS and 10% and 73% had intermediate and unfavorable risk disease by ELN, respectively (Table 1). 732 adverse events (AEs) occurred; 46 (6%) were serious, the most common were neutropenic fever (37%) and pneumonia (13%). The most common >grade 2 related AEs were leukopenia (53%), thrombocytopenia (44%) and neutropenia (35%); there were no related grade 5 AEs. The overall response rate was 70% (21/30; CR=19, MLFS=2). Median number of cycles to achieve best response was 1. Significant blast reductions were seen on day 8; of the 28 with interpretable day 8 BMBXs, 10 achieved MLFS on day 8. 4 completed ≥1 cycle and were refractory. An additional 4 did not complete cycle 1: 1 died of disease and 3 elected to come off therapy (all subsequently died of disease). Four (19%) responders relapsed, after a median 180 days (27-279). With median follow up of 214 days, median response duration has not been reached. 10 patients died, after a median 65 days (29-256); 1/30 died within 30 days. Median overall survival has not been reached. Of the 26 who completed ≥1 cycle, 19 were MRD- by MPFC, including 18/19 who achieved CR. Of these 26, 3 were not monitored by ddPCR: for 2 patients this was due to the absence of detectable baseline mutations and for 1 patient it was due to refractory disease. The remaining 23 had ddPCR monitoring; 3 became MRD- by this modality (Fig 2). All 3 were also MRD- by MPFC and per protocol discontinued aza and initiated ven maintenance (Fig 1). MRD negativity by both parameters occurred after cycles 1, 2 and 3, respectively. One MRD- patient relapsed after 216 days; two remain in remission after 301 and 124 days. An additional 4 who achieved MRD+ responses discontinued aza at their insistence (and in violation of the protocol); 1 relapsed after 279 days, and 3 remain in ongoing remission. Univariate predictors of refractory disease were FAB M0/M1 (OR 0.070, p=0.02) and RAS pathway mutations (OR 14.25, p=0.02). Conclusions: Higher initial doses of ven are tolerated in this population. Blast reduction occurs quickly in many patients (day 8), for this low intensity regimen. Response rates are consistent with lower doses of ven. Very deep responses, as measured by highly sensitive MRD methods (MPFC and ddPCR are capable of sensitivity up to 0.02%), are attainable. Longer follow up time will determine if higher ven doses and MRD-driven decisions related to continuation of aza result in more durable responses. Increased maturation of blasts and RAS pathway mutations are predictors for refractory disease. Disclosures Lyle: Pfizer: Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo Incyte: Membership on an entity's Board of Directors or advisory committees; Agios: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees. Pollyea:Agios: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Astellas: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celyad: Consultancy, Membership on an entity's Board of Directors or advisory committees; Diachii Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Forty-Seven: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Published
2019

14. Reliability, Validity, and Responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index for Elderly Patients with a Femoral Neck Fracture

Author

Paul T.P.W. Burgers, Rudolf W Poolman, Theodorus MJ Van Bakel, Wim E Tuinebreijer, Stephanie M Zielinski, Mohit Bhandari, Peter Patka, Esther MM Van Lieshout, P J Devereaux, Gordon H Guyatt, Thomas A Einhorn, Lehana Thabane, Emil H Schemitsch, Kenneth J Koval, Frede Frihagen, Kevin Tetsworth, Ernesto Guerra-Farfan, Stephen D Walter, Sheila Sprague, Marilyn Swinton, Taryn Scott, Paula McKay, Kim Madden, Diane Heels-Ansdell, Lisa Buckingham, Aravin Duraikannan, Heather Silva, Martin J Heetveld, Robert D Zura, Victoria Avram, Ajay Manjoo, Dale Williams, John Antoniou, Tim Ramsay, Earl R Bogoch, Andrew Trenholm, Stephen Lyman, Madhu Mazumdar, Kevin J Bozic, Mark Luborsky, Stuart Goodman, Susan Muray, Rob Korley, Richard Buckley, Paul Duffy, Shannon Puloski, Kimberly Carcary, Melissa Lorenzo, Michael D McKee, Jeremy A Hall, Aaron Nauth, Daniel Whelan, Timothy R Daniels, James P Waddell, Henry Ahn, Milena R Vicente, Jennifer T Hidy, Melanie T MacNevin, Hans Kreder, Terry Axelrod, Richard Jenkinson, Markku Nousiainen, David Stephen, Veronica Wadey, Monica Kunz, Katrine Milner, Ria Cagaanan, Melanie MacNevin, Peter J O’Brien, Piotr A Blachut, Henry M Broekhuyse, Pierre Guy, Kelly A Lefaivre, Gerard P Slobogean, Raman Johal, Irene Leung, Chad Coles, Ross Leighton, C. Glen Richardson, Michael Biddulph, Michael Gross, Michael Dunbar, J. David Amirault, David Alexander, Catherine Coady, Mark Glazebrook, David Johnston, William Oxner, Gerald Reardon, Ivan Wong, Kelly Trask, Shelley MacDonald, Andrew Furey, Craig Stone, Minnie Parsons, Trevor Stone, Mauri Zomar, Robert McCormack, Kelly Apostle, Dory Boyer, Farhad Moola, Bertrand Perey, Darius Viskontas, Karyn Moon, Raely Moon, Yves Laflamme, Benoit Benoit, Pierre Ranger, Michel Malo, Julio Fernandes, Karine Tardif, Julie Fournier, Pascal André Vendittoli, Vincent Massé, Alain G Roy, Martin Lavigne, Daniel Lusignan, Craig Davis, Philip Stull, Stewart Weinerman, Peter Weingarten, Steven Lindenbaum, Michael Hewitt, Rebecca Danielwicz, Janell Baker, Michael Mont, Donald E Delanois, Bhaveen Kapadia, Kimona Issa, Marylou Mullen, Andrew Sems, Barb Foreman, Javad Parvizi, Tiffany Morrison, Courtland Lewis, Stephanie Caminiti, Paul Tornetta, William R Creevy, Michelle J Lespasio, Hope Carlisle, Andrew Marcantonio, Michael Kain, Lawrence Specht, John Tilzey, John Garfi, Samir Mehta, John L Esterhai, Jaimo Ahn, Derek Donegan, Annamarie Horan, Kelly McGinnis, James Roberson, Thomas Bradbury, Greg Erens, Kyle Webb, Brian Mullis, Karl Shively, Andrew Parr, Janos Ertl, Ripley Worman, Mark Webster, Judd Cummings, Valda Frizzell, Molly Moore, Clifford B Jones, James R Ringler, Debra L Sietsema, Jane E Walker, Enes Kanlic, Amr Abdelgawad, Juan Shunia, Charles DePaolo, Susan Sutherland, Rachel Alosky, Robert Zura, Maria Manson, Gregg Strathy, Kathleen Peter, Paul Johnson, Meaghan Morton, James Shaer, Tyson Schrickel, Barbara Hileman, Marina Hanes, Elisha Chance, E. Matthew Heinrich, David Dodgin, Michele LaBadie, David Zamorano, Martin Tynan, Ran Schwarzkopf, John A Scolaro, Ranjan Gupta, Samuel Bederman, Nitin Bhatia, Bang Hoang, Douglas Kiester, Neil Jones, Gregory Rafijah, Damon Alavekios, Jason Lee, Akshay Mehta, Steven Schroder, Tom Chao, Vincent Colin, Phuc (Phil) Dang, Stephen Keun Heng, Gregory Lopez, Samuel Galle, Sohrab Pahlavan, Duy L Phan, Minal Tapadia, Christopher Bui, Nickul Jain, Tyler Moore, Nathan Moroski, Deeba Pourmand, Erik N Kubiak, Jeremy Gililland, David Rothberg, Christopher Peters, Christopher Pelt, Ami R Stuart, Kirby Corbey, Franklin D Shuler, James Day, Tigran Garabekyan, Felix Cheung, Ali Oliashirazi, Jonathon Salava, Linda Morgan, Timothy Wilson-Byrne, Mary Beth Cordle, Leon H.G.J. Elmans, Joost A.A.M. van den Hout, Adrianus JP Joosten, Ad FA van Beurden, Stefan BT Bolder, Denise Eygendaal, Adrianus F.C.M. Moonen, Rutger CI van Geenen, Eric A Hoebink, Robert Wagenmakers, Wouter van Helden, Hans-Peter W van Jonbergen, Herbert Roerdink, Joost M Reuver, Alexander FW Barnaart, Elvira R Flikweert, Rover Krips, J. Bernard Mullers, Hans Schüller, Mark LM Falke, Frans J Kurek, Adrianus CH Slingerland, Jan P van Dijk, Wouter H van Helden, Hugo W Bolhuis, Pieter HJ Bullens, Mike Hogervorst, Karin E de Kroon, Rob H Jansen, Ferry Steenstra, Eric EJ Raven, W. Peter J Fontijne, Saskia C Wiersma, Bastiaan Boetes, Edgar JT ten Holder, Huub JL van der Heide, Jochem Nagels, Enrike H.M.J. van der Linden-van der Zwaag, Stefan B Keizer, Jan-Willem A Swen, Peter HC den Hollander, Bregje JW Thomassen, Willem Jan Kleyn Molekamp, Frank R.A.J. de Meulemeester, Arthur EB Kleipool, Robert Haverlag, Maarten P Simons, Eduard L.A.R. Mutsaerts, Rob Kooijman, Roelf R Postema, René J.T.M. Bleker, Harald IH Lampe, Lein Schuman, John Cheung, Frank van Bommel, W. Paul Winia, Daniel Haverkamp, Harm van der Vis, Peter A Nolte, Michel PJ van den Bekerom, Tjitte de Jong, Arthur van Noort, Diederik A Vergroesen, Bernard G Schutte, Harm M van der Vis, Lijkele Beimers, Jasper de Vries, Arthur W Zurcher, G.H. Rob Albers, Maarten Rademakers, Stefan Breugem, Ibo van der Haven, Pieter Jan Damen, Gythe H Bulstra, Martin M Campo, Mathijs P Somford, Daniël Haverkamp, Susan Liew, Harvinder Bedi, Ashley Carr, Andrew Chia, Steve Csongvay, Craig Donohue, Stephen Doig, Elton Edwards, Max Esser, Richard Freeman, Andrew Gong, Doug Li, Russell Miller, Lu Ton, Otis Wang, Ian Young, Adam Dowrick, Zoe Murdoch, Claire Sage, Richard Page, David Bainbridge, Richard Angliss, Ben Miller, Andrew Thomson, Graeme Brown, Simon Williams, Kevin Eng, David Bowyer, John Skelley, Chatar Goyal, Sally Beattie, Enrique Guerado, Encarnacion Cruz, Juan Ramon Cano, Miguel Angel Froufe, Lluis Marull Serra, Samer Al-dirra, Cristina Martinez, Francisco José Tarazona Santabalbina, Jordi Teixidor Serra, Jordi Tomas Hernandez, Marc Aguilar Garcia, Vicente Molero Garcia, Sergi Barrera, Miriam Garrido, Lars Nordsletten, John Clarke-Jenssen, Geir Hjorthaug, Anne Christine Brekke, Elise Berg Vesterhus, Ingunn Skaugrud, Pradeep Tripathi, Sandesh Katiyar, Preksha Shukla, Marc Swiontkowski, Gordon Guyatt, Kyle Jeray, Stephen Walter, Helena Viveiros, Victoria Truong, Kaitlin Koo, Qi Zhou, Deborah Maddock, Nicole Simunovic, Julie Agel, Amar Rangan, Birgit C Hanusch, Lucksy Kottam, Rachel Clarkson, Gregory J Della Rocca, Gerard Slobogean, Jeffrey Katz, Brenda Gillespie, Gail A Greendale, Curtis Hartman, Craig Rubin, James Waddell, H. Michael Lemke, Amber Oatt, Richard E Buckley, Robert Korley, Kelly Johnston, James Powell, David Sanders, Abdel Lawendy, Christina Tieszer, John Murnaghan, Diane Nam, Albert Yee, Daniel B Whelan, Lisa M Wild, Ryan M Khan, Cathy Coady, David Amirault, Glen Richardson, Gwen Dobbin, Ryan Bicknell, Jeff Yach, Davide Bardana, Gavin Wood, Mark Harrison, David Yen, Sue Lambert, Fiona Howells, Angela Ward, Paul Zalzal, Heather Brien, V Naumetz, Brad Weening, Eugene K Wai, Steve Papp, Wade T Gofton, Stephen P Kingwell, Garth Johnson, Joseph O’Neil, Darren M Roffey, Vivian Borsella, Todd M Oliver, Vicki Jones, Terrence J Endres, Samuel G Agnew, Kyle J Jeray, J. Scott Broderick, David R Goetz, Thomas B Pace, Thomas M Schaller, Scott E Porter, Stephanie L Tanner, Rebecca G Snider, Lauren A Nastoff, Shea A Bielby, Julie A Switzer, Peter A Cole, Sarah A Anderson, Paul M Lafferty, Mengnai Li, Thuan V Ly, Scott B Marston, Amy L Foley, Sandy Vang, David M Wright, Andrew J Marcantonio, Michael SH Kain, Richard Iorio, Lawrence M Specht, John F Tilzey, Margaret J Lobo, John S Garfi, Heather A Vallier, Andrea Dolenc, Chalitha Robinson, Michael J Prayson, Richard Laughlin, L. Joseph Rubino, Jedediah May, Geoffrey Ryan Rieser, Liz Dulaney-Cripe, Chris Gayton, John T Gorczyca, Jonathan M Gross, Catherine A Humphrey, Stephen Kates, Krista Noble, Allison W McIntyre, Kaili Pecorella, Craig A Davis, Stephen Lindenbaum, John Schwappach, Janell K Baker, Tori Rutherford, Heike Newman, Shane Lieberman, Erin Finn, Kristin Robbins, Meghan Hurley, Lindsey Lyle, Khalis Mitchell, Kieran Browner, Erica Whatley, Krystal Payton, Christina Reeves, Lisa K Cannada, David Karges, Leslie Hill, John Esterhai, Annamarie D Horan, Christine A Kaminski, Brynn N Kowalski, Jonathan P Keeve, Christopher G Anderson, Michael D McDonald, Jodi M Hoffman, Ivan Tarkin, Peter Siska, Gary Gruen, Andrew Evans, Dana J Farrell, James Irrgang, Arlene Luther, William W Cross, Joseph R Cass, Stephen A Sems, Michael E Torchia, Tyson Scrabeck, Mark Jenkins, Jules Dumais, Amanda W Romero, Carlos A Sagebien, Mark S Butler, James T Monica, Patricia Seuffert, Joseph R Hsu, James Ficke, Michael Charlton, Matthew Napierala, Mary Fan, Chadi Tannoury, Michael Archdeacon, Ryan Finnan, Toan Le, John Wyrick, Shelley Hess, Michael L Brennan, Robert Probe, Evelyn Kile, Kelli Mills, Lydia Clipper, Michelle Yu, Katie Erwin, Daniel Horwitz, Kent Strohecker, Teresa K Swenson, Andrew H Schmidt, Jerald R Westberg, Kamran Aurang, Gary Zohman, Brett Peterson, Roger B Huff, Joseph Baele, Timothy Weber, Matt Edison, Jessica McBeth, Janos P Ertl, J. Andrew Parr, Molly M Moore, Erin Tobias, Emily Thomas, Charles J DePaolo, Leslie E Shell, Lynne Hampton, Stephanie Shepard, Tracy Nanney, Claudine Cuento, Robert V Cantu, Eric R Henderson, Linda S Eickhoff, E. Mark Hammerberg, Philip Stahel, David Hak, Cyril Mauffrey, Douglas Gibula, Hannah Gissel, Corey Henderson, David P Zamorano, Martin C Tynan, Deanna Lawson, Brett D Crist, Yvonne M Murtha, Linda K Anderson, Colleen Linehan, Lindsey Pilling, Courtland G Lewis, Raymond J Sullivan, Elizabeth Roper, William Obremskey, Philip Kregor, Justin E Richards, Kenya Stringfellow, Michael P Dohm, Abby Zellar, Michiel JM Segers, Jacco AC Zijl, Bart Verhoeven, Anke B Smits, Jean Paul PM de Vries, Bram Fioole, Henk van der Hoeven, Evert BM Theunissen, Tammo S de Vries Reilingh, Lonneke Govaert, Philippe Wittich, Maurits de Brauw, Jan Wille, Peter M.N.Y.M. Go, Ewan D Ritchie, Ronald N Wessel, Eric R Hammacher, Gijs A Visser, Heyn Stockmann, Rob Silvis, Jaap P Snellen, Bram Rijbroek, Joris JG Scheepers, Erik GJ Vermeulen, Michiel PC Siroen, Ronald Vuylsteke, Hans LF Brom, Herman Rijna, Piet AR de Rijcke, Cees L Koppert, Steven E Buijk, Richard PR Groenendijk, Imro Dawson, Geert WM Tetteroo, Milko MM Bruijninckx, Pascal G Doornebosch, Eelco JR de Graaf, Maarten van der Elst, Carmen C van der Pol, Martijne van’t Riet, Tom M Karsten, Mark R de Vries, Laurents PS Stassen, Niels WL Schep, G Ben Schmidt, W H Hoffman, Frank H.W.M. van der Heijden, W. Jaap Willems, Cor P van der Hart, Kahn Turckan, Sebastiaan Festen, Frank de Nies, Nico JM Out, Jan Bosma, Albert van Kampen, Jan Biert, Arie B van Vugt, Michael JR Edwards, Taco J Blokhuis, Jan Paul M Frölke, Leo MG Geeraedts, Jean WM Gardeniers, Edward T.C.H. Tan, Lodewijk M.S.J. Poelhekke, Maarten C de Waal Malefijt, Bart Schreurs, Gert R Roukema, Hong A Josaputra, Paul Keller, Peter D de Rooij, Hans Kuiken, Han Boxma, Berry I Cleffken, Ronald Liem, Steven J Rhemrev, Coks HR Bosman, Alexander de Mol van Otterloo, Jochem Hoogendoorn, Alexander C de Vries, Sven AG Meylaerts, Michiel HJ Verhofstad, Joost Meijer, Teun van Egmond, Igor van der Brand, Martin G Eversdijk, Rolf Peters, Dennis Den Hartog, Oscar JF Van Waes, Pim Oprel, Martin Campo, Ronald Verhagen, G.H. Robert Albers, Rogier KJ Simmermacher, Jeroen van Mulken, Karlijn van Wessem, Steven M van Gaalen, Luke PH Leenen, Maarten W.G.A. Bronkhorst, Onno R Guicherit, J. Carel Goslings, Kees Jan Ponsen, Mahesh Bhatia, Vinod Arora, Vivek Tyagi, Ajay Gupta, Neeraj Jain, Farah Khan, Ateet Sharma, Amir Sanghavi, Mittal Trivedi, Anil Rai, null Subash, Kamal Rai, Vineet Yadav, Sanjay Singh, Amal Shankar Prasad, Vimlesh Mishra, D C Sundaresh, Angshuman Khanna, Joe Joseph Cherian, Davy J Olakkengil, Gaurav Sharma, Akhil Dadi, Naveen Palla, Utsav Ganguly, B. Sachidananda Rai, Janakiraman Rajakumar, Peter Hull, Sophie Lewis, Simone Evans, Rajesh Nanda, Rajanikanth Logishetty, Sanjeev Anand, Carol Bowler, Andrew Jennings, Graham Chuter, Glynis Rose, Gillian Horner, Callum Clark, Kate Eke, Mike Reed, Chris Herriott, Christine Dobb, Hamish Curry, Greg Etherington, Arvind Jain, Ash Moaveni, Matthias Russ, Geoff Donald, Patrick Weinrauch, Paul Pincus, Steven Yang, Brett Halliday, Trevor Gervais, Michael Holt, Annette Flynn, Marinis Pirpiris, David Love, Andrew Bucknill, Richard J Farrugia, Torben Ianssen, Asgeir Amundsen, Jan Egil Brattgjerd, Tor Borch, Berthe Bøe, Bernhard Flatøy, Sondre Hasselund, Knut Jørgen Haug, Kim Hemlock, Tor Magne Hoseth, Geir Jomaas, Thomas Kibsgård, Tarjei Lona, Gilbert Moatshe, Oliver Müller, Marius Molund, Tor Nicolaisen, Fredrik Nilsen, Jonas Rydinge, Morten Smedsrud, Are Stødle, Axel Trommer, Stein Ugland, Anders Karlsten, Guri Ekås, Hans-Christoph Pape, Matthias Knobe, Roman Pfeifer, Orthopedic Surgery and Sports Medicine, Graduate School, Other departments, Surgery, Other Research, Amsterdam Movement Sciences, Cardiothoracic Surgery, and Emergency Medicine

Subjects
Male, medicine.medical_specialty, WOMAC, Abstracting and Indexing, Osteoarthritis, Cronbach's alpha, Surveys and Questionnaires, medicine, Humans, Orthopedics and Sports Medicine, Clinical significance, Femoral neck, Aged, 80 and over, Ontario, business.industry, Reproducibility of Results, Construct validity, General Medicine, medicine.disease, RELIABILITY VALIDITY, Femoral Neck Fractures, Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10], Clinical trial, Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], medicine.anatomical_structure, Physical therapy, Female, Surgery, business
Abstract

Item does not contain fulltext BACKGROUND: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been extensively evaluated in groups of patients with osteoarthritis, yet not in patients with a femoral neck fracture. This study aimed to determine the reliability, construct validity, and responsiveness of the WOMAC compared with the Short Form-12 (SF-12) and the EuroQol 5D (EQ-5D) questionnaires for the assessment of elderly patients with a femoral neck fracture. METHODS: Reliability was tested by assessing the Cronbach alpha. Construct validity was determined with the Pearson correlation coefficient. Change scores were calculated from ten weeks to twelve months of follow-up. Standardized response means and floor and ceiling effects were determined. Analyses were performed to compare the results for patients less than eighty years old with those for patients eighty years of age or older. RESULTS: The mean WOMAC total score was 89 points before the fracture in the younger patients and increased from 70 points at ten weeks to 81 points at two years postoperatively. In the older age group, these scores were 86, 75, and 78 points. The mean WOMAC pain scores before the fracture and at ten weeks and two years postoperatively were 92, 76, and 87 points, respectively, in the younger age group and 92, 84, and 93 points in the older age group. Function scores were 89, 68, and 79 points for the younger age group and 84, 71, and 73 points for the older age group. The Cronbach alpha for pain, stiffness, function, and the total scale ranged from 0.83 to 0.98 for the younger age group and from 0.79 to 0.97 for the older age group. Construct validity was good, with 82% and 79% of predefined hypotheses confirmed in the younger and older age groups, respectively. Responsiveness was moderate. No floor effects were found. Moderate to large ceiling effects were found for pain and stiffness scales at ten weeks and twelve months in younger patients (18% to 36%) and in the older age group (38% to 53%). CONCLUSIONS: The WOMAC showed good reliability, construct validity, and responsiveness in both age groups of elderly patients with a femoral neck fracture who had been physically and mentally fit before the fracture. The instrument is suitable for use in future clinical studies in these populations. CLINICAL RELEVANCE: The results are based on two clinical trials. The questionnaires used concern pure, clinically relevant issues (ability to walk, climb stairs, etc.). Moreover, the results can be used for future research comparing clinical outcomes (or treatments) for populations with a femoral neck fracture.

Published
2015

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