The OUTLET Study, the LEAP Study, and the Challenges of Conducting Observational Trials and RCTs

OrthoJOE

In this episode, Mo and Marc discuss the challenges of conducting high-quality observational trials and the dangers of publishing poorly designed RCTs, with an emphasis on the concept that high quality leads to high impact.

Links:

• Fram BR, Bosse MJ, Odum SM, Reider L, Gary JL, Gordon WT, Teague D, Alkhoury D, MacKenzie EJ, Seymour RB, Karunakar MA; The Major Extremity Trauma Research Consortium. Do Transtibial Amputations Outperform Amputations of the Hind- and Midfoot Following Severe Limb Trauma?: A Secondary Analysis of the OUTLET Study. J Bone Joint Surg Am. 2024 May 1;106(9):776-781. doi: 10.2106/JBJS.23.00878. Epub 2024 Mar 21. PMID: 38512987. https://bit.ly/3WJEjIy
• Bosse MJ, MacKenzie EJ, Kellam JF, Burgess AR, Webb LX, Swiontkowski MF, Sanders RW, Jones AL, McAndrew MP, Patterson BM, McCarthy ML, Travison TG, Castillo RC. An analysis of outcomes of reconstruction or amputation after leg-threatening injuries. N Engl J Med. 2002;347:1924-31. https://pubmed.ncbi.nlm.nih.gov/12477942/
• MacKenzie EJ, Bosse MJ, Pollak AN, Webb LX, Swiontkowski MF, Kellam JF, Smith DG, Sanders RW, Jones AL, Starr AJ, McAndrew MP, Patterson BM, Burgess AR, Castillo RC. Long-term persistence of disability following severe lower-limb trauma. Results of a seven-year follow-up. J Bone Joint Surg Am. 2005 Aug;87(8):1801-9. doi: 10.2106/JBJS.E.00032. PMID: 16085622. https://bit.ly/3UZfhE3

Subspecialties:

• Rehabilitation
• Trauma