Background A lack of racial and ethnic representation in clinical trials may limit the generalizability of the orthopaedic evidence base as it applies to patients in underrepresented minority populations and perpetuate existing disparities in use, complications, or functional outcomes. Although some commentators have implied the need for mandatory race or ethnicity reporting across all orthopaedic trials, the usefulness of race or ethnic reporting likely depends on the specific topic, prior evidence of disparities, and individualized study hypotheses. Questions/purposes In a systematic review, we asked: (1) What proportion of orthopaedic clinical trials report race or ethnicity data, and of studies that do, how many report data regarding social covariates or genomic testing? (2) What trends and associations exist for racial and ethnic reporting among these trials between 2000 and 2020? (3) What is the racial or ethnic representation of United States trial participants compared with that reported in the United States Census? Methods We performed a systematic review of randomized controlled trials with human participants published in three leading general-interest orthopaedic journals that focus on clinical research: The Journal of Bone and Joint Surgery, American Volume; Clinical Orthopaedics and Related Research; and Osteoarthritis and Cartilage. We searched the PubMed and Embase databases using the following inclusion criteria: English-language studies, human studies, randomized controlled trials, publication date from 2000 to 2020, and published in Clinical Orthopaedics and Related Research; The Journal of Bone and Joint Surgery, American Volume; or Osteoarthritis and Cartilage. Primary outcome measures included whether studies reported participant race or ethnicity, other social covariates (insurance status, housing or homelessness, education and literacy, transportation, income and employment, and food security and nutrition), and genomic testing. The secondary outcome measure was the racial and ethnic categorical distribution of the trial participants included in the studies reporting race or ethnicity. From our search, 1043 randomized controlled trials with 184,643 enrolled patients met the inclusion criteria. Among these studies, 21% (223 of 1043) had a small (< 50) sample size, 56% (581 of 1043) had a medium (50 to 200) sample size, and 23% (239 of 1043) had a large (> 200) sample size. Fourteen percent (141 of 1043) were based in the Northeast United States, 9.2% (96 of 1043) were in the Midwest, 4.7% (49 of 1043) were in the West, 7.2% (75 of 1043) were in the South, and 65% (682 of 1043) were outside the United States. We calculated the overall proportion of studies meeting the inclusion criteria that reported race or ethnicity. Then among the subset of studies reporting raceThe authors certify that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted...
Background:We systematically reviewed the radiological outcomes of studies comparing robotic-assisted (RA-THA) and manual total hip arthroplasty (mTHA). Methods:The PubMed, Embase, and Cochrane databases were queried from 1994-2021 for articles comparing radiographic outcomes between RA-THA and mTHA cohorts. A meta-analysis was conducted whenever sufficient data was present for common outcomes.Results: Our analysis included 20 articles reporting on 4140 patients (RA-THA: n = 1228; mTHA: n = 2912). No differences were demonstrated for acetabular inclination or anteversion. However, RA-THA demonstrated higher rates of cup orientation within the Lewinnek and Callanan safe zones, improved femoral stem alignment, and lower global offset difference (GOD) and limb length discrepancy (all p-values <0.05). Superior femoral canal fill and combined offset were seen among RA-THA patients. Conclusion:Our review found that the use of RA-THA yields superior radiographic outcomes compared to mTHA counterparts. This information can inform healthcare systems considering investing in and implementing these technologies.
What is known and Objective:: Warfarin is a widely used anticoagulant, well‐known for its interactions with medications and foods. Vaccinations, particularly the influenza vaccine, have been thought to potentially interfere with anticoagulation response in those on chronic warfarin. Our objective was to systematically review the literature to assess the validity and clinical significance of this association. Methods:: A primary literature search was performed using MEDLINE (1966 – June 2011) and EMBASE (1980 – June 2011). Additional studies were obtained by performing a manual bibliographical review of literature from the initial results and by searching The Cochrane Database of Systematic Reviews. All English‐language, peer‐reviewed publications identified were evaluated. Reviews, case studies and trials reporting anticoagulation response using an unconverted prothrombin time ratio were excluded. Results and Discussion:: Thirty‐one abstracts were initially reviewed, and seven studies were identified for inclusion in this review. Significant changes in mean INR post‐vaccination between the study and comparator groups were documented in one trial. Through subgroup analysis, another study noted that elderly patients spent more time in the subtherapeutic range post‐vaccination when compared with baseline INR levels. No other significant changes in mean INR levels were documented following influenza vaccination. Adverse bleeding events reported after immunization were limited and minor in nature. What is new and Conclusion:: Overall, our review does not indicate a consistent, clinically relevant effect of influenza vaccines on INR of patients on chronic warfarin therapy. Isolated reports of variations in INR following influenza vaccination are likely due to other factors.
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