Analysis of changing statistical significance from .05 to .005 in foot and ankle randomized controlled trials

Background: Misinterpretation of p-values in RCTs is extremely problematic since they are the core basis for high levels of recommendation in clinical practice guidelines, especially Orthopaedics. Benjamin et al. proposed a universal protocol change, moving statistical significance from a p-value of .05 to .005 to combat the misinterpretation that is happening in medical literature. In this study, we are looking to evaluate the effect of the protocol suggested by Benjamin et al. on foot and ankle-related RCTs in the top 3 Foot and Ankle-related journals.Methods: We conducted a Pubmed search looking at studies published from January 1st, 2016 to November 10, 2021, in the following three journals; Foot and Ankle International, Journal of Foot and Ankle Surgery, and Foot & Ankle International. The inclusion criteria for the study were RCTs published in the above journals with specifically stated primary endpoints. If a study has multiple primary endpoints, all were included. Exclusion criteria were any study that was not prospective and randomized by design, also any study that did not state primary endpoints was excluded. Two authors extracted the data using a pilot-tested Google form, any disagreements or questions were resolved by published methodologic orthopaedic authors.Results: Of the 222 endpoints, 101 endpoints (45.5%; 101/222) were at or below the .05 threshold while 121 endpoints (54.5%; 121/222) were above the .05 threshold. We also found that 59 endpoints (26.6%; 59/222) were below .005.Conclusion: Our results suggest that changing the threshold for statistical significance from .05 to .005 in foot and ankle RCTs would heavily alter literature published in the field. By implementing this methodology, it is a promising measure to be able to increase RCT quality until a more substantial solution can be found. With that being said, caution must be taken when interpreting our results, also requiring further evaluation

COVID 19 and its effects on pediatric orthopaedic clinical trials

Background: Clinical trials for the treatment of pediatric orthopaedics are critical to enhance the quality of life of these children. In response to the COVID-19 pandemic, the FDA updated guidance on conducting clinical trials to prioritize patient safety; however the degree to which the pandemic disrupted pediatric orthopaedic-related clinical trials is unknown. Thus, our objective is to quantify the number of these trials disrupted due to the COVID-19 pandemic.Methods: We searched ClinicalTrials.gov for ongoing and discontinued trials between 01/01/2020 - 10/31/2021. Trials were screened for relevance to the study and the number of participants, trial location, funding source, and reason for discontinuation. Associations between reasons for termination, funding source, trial location, and the number of participants enrolled were evaluated using MannWhitney U tests or ANOVA, where appropriate.Results: Our search returned 544 trials, of which 128 were included with a total of 15,194 participants. Of the included Pediatric trials of orthopaedic conditions, 9 were discontinued with a total of 497 participants. Of the 9 discontinued trials, 1 of 3 stated COVID-19 as a reason. Mann-Whitney U tests and ANOVA showed no statistically significant difference in enrollment between trials discontinued due to COVID-19 compared to other discontinued trials, nor among funding or location.Conclusion: Our study shows 33% of discontinued pediatric orthopaedic-related clinical trials cited COVID-19 as a reason for discontinuation; however, only 12% of all children enrolled in discontinued trials. Findings from this study highlight the importance of developing strategies for safely continuing clinical research amid global emergencies that will almost certainly arise in the future

Do all bunions need surgery? An investigation of Google searches for Hallux Valgus

Introduction: Hallux valgus (HV) or a bunion is one of the most common forefoot deformities. Approximately one in four adults will develop HV with a higher prevalence in adult females. Given the high prevalence of HV along with the wide variety of non-surgical and surgical treatment options for it, we believe patients are likely turning to internet search engines for questions germane to HV. Previous orthopaedic investigations have used Google’s “People Also Ask” box to characterize frequently asked questions (FAQs) regarding total knee and hip arthroplasty. Yet, no such investigation has been conducted for HV. Using Google’s Frequently Asked Questions (FAQs), we sought to classify these questions as well as assess their levels quality and transparency.Methods: On October 9, 2022, we searched Google using these four phrases: “Hallux Valgus Treatment,” “Hallux Valgus Treatment Surgery,” “Bunion Treatment,” and “Bunion Surgery.” We refreshed search results until a minimum of 100 FAQs were produced; we extracted the sources of these 100 questions for content analysis. Information transparency was assessed using the Journal of the American Medical Association’s (JAMA) Benchmark tool, question classification was defined using the Rothwell Classification of Questions, and information quality was assessed using Brief DISCERN. This study was approved by an IRB.Results section: Our Google search returned 299 unique FAQs after removing duplicates and unrelated FAQs. The majority were classified as fact based questions (149/299, 49.8%), followed by value (92/299, 30.8%) and policy questions (58/299, 19.4%). Overall the most common topic searched was related to the evaluation of treatment or surgery (79/299, 26.4%). The frequent answer sources were medical practices (158/299, 52.8%), followed by commercial (69/299, 23.1%) and academic (38/299, 12.7%). The one-way analysis of variance revealed a significant difference in mean quality scores among the 5 source types (F= 54.49, P<.001) with medical practices averaging the worst score (12.1/30) compared to academic sources which were found to have the highest score (21.8/30).Discussion: Patients seeking online information concerning treatment options for HV appear to search Google for questions related to treatment efficacy and restrictions. The most common source type encountered by patients are small medical practices; these were found to have both poor transparency and poor quality. Our study has several limitations, JAMA benchmark and Brief DISCERN do not assess the accuracy of the information. Secondly, our study is cross-sectional in design limiting the generalizability of our findings to the time when the search was performed.Significance/Clinical Relevance: In order to increase the transparency and quality of online information regarding HV treatment, online sources should refer to established rubrics such as JAMA benchmark and Brief DISCERN when publishing online information. Physicians should be aware that patients are commonly searching for information related to the evaluation of treatments or surgeries for HV

Education Research in Orthopaedic Surgery

Introduction:. With the ever-changing dynamics of surgical training, it is essential for the content of educational research to evolve simultaneously. This study aimed to assess the current state of scholarly work in orthopaedic training education and to identify particular educational topics that are trending in the literature. Methods:. A PubMed search string was used to identify literature on orthopaedic surgery education from 2016 to 2021. Publications on orthopaedic surgery education were divided into 8 education-based categories: (1) operative training and simulation, (2) curriculum and career development, (3) diversity, (4) wellness and burnout, (5) program evaluation and match data, (6) trainee assessments, (7) social media, and (8) other. Univariate analysis and linear regression were used to determine trends. Results:. A total of 383 orthopaedic surgery education publications met inclusion criteria. Orthopaedic surgery education publications accounted for 0.47% of the total publications from all 54 journals. Fifteen journals provided 85% of all orthopaedic education publications (N = 325). The Journal of Bone and Joint Surgery produced the most orthopaedic surgery education publications (76, 20%), followed by the Journal of Surgical Education (62, 16%) and the Journal of the American Academy of Orthopaedic Surgeons (58, 15%). Publications on curriculum and career development were the most common (21.9%). The following most frequent topics were program evaluation and match data (20.9%) and operative training and simulation (18%), respectively. Over the study period, the total amount of orthopaedic surgery education articles increased significantly (R2 = 0.86, p = 0.008). Articles included all levels of training, with resident education accounting for the majority, with 269 articles (70.2%). Conclusion:. Recent trends in orthopaedic literature indicate an increased emphasis on education as the number of publications has increased, but are still sparse in orthopaedic literature. As the field of orthopaedics continues to advance, we recommend that academic institutions and organizations continue to evaluate and promote evidence-based educational research to ensure that orthopaedic education meets the ever-increasing demands that residents and practicing surgeons will face in the present and future. Level of Evidence:. II

Statistical significance and orthopaedic traumatology

Purpose of Study: A recent proposal suggests changing the threshold for statistical significance from a P value of .05 to .005 to minimize bias and increase reproducibility of future studies. The present study explores how lowering the P value threshold would affect the interpretation of previously published trauma orthopaedic randomized clinical trials (RCTs) and whether outcomes from these trials would maintain statistical significance under the proposed P value threshold.Methods: All RCTs published between January 01, 2016 and January 31, 2018 in the Journal of Orthopaedic Trauma, Injury, and Archives of Orthopaedic and Trauma Surgery screened by at least 2 authors. Data from included trials were extracted in blinded and duplicate fashion.Results: Of 75 articles retrieved, 49 were included. We identified 117 primary endpoints from 49 trials: 41 endpoints (35.0%) had a P value less than .05 and 76 (65.0%) had a P value greater than .05. Overall, 41.5% (17/41) of statistically significant primary endpoints were less than .005. Of the 117 primary endpoints, only 17 (14.5%) of the endpoints were less than .005, and would hold significance with the proposed threshold. Only 6.12% (3/49) of the included studies had all primary endpoints that met the new threshold of .005.Conclusion: Based on our results, adopting a lower threshold of significance would heavily alter the significance of orthopaedic trauma RCTs and should be further evaluated and cautiously considered when viewing the impact it may have on orthopaedic practice

Cemented vs Uncemented hemiarthroplasties for femoral neck fractures: An overlapping systematic review and evidence appraisal

Background The purpose of our study is to assess the methodology of overlapping systematic reviews related to cemented vs uncemented hip hemiarthroplasties for the treatment of femoral neck fractures to find the study with the best evidence. Also, we assess the gaps in methodology and information to help with direction of future studies. Methods A systematic search was conducted in September 2022 using Pubmed, Embase, and Cochrane Library. Clinical outcome data and characteristics of each study were extracted to see which treatment had better favorability. The outcomes and characteristics extracted from each study includes, first author, search date, publication journal and date, number of studies included, databases, level of evidence, software used, subgroup analyses that were conducted, and heterogeneity with the use of I2 statistics Methodological quality information was extracted from each study using four different methodologic scores (Oxford Levels of Evidence; Assessment of Multiple Systematic Reviews (AMSTAR); Quality of reporting of meta-analyses (QUROM); Oxman and Guyatt. After that, the Jadad decision algorithm was used to identify which studies in our sample contained the best available evidence. Finally, overlap of each systematic review was assessed using Corrected Covered Area (CCA) to look at redundancy and research waste among the systematic reviews published on the topic. Results After screening, 12 studies were included in our sample. For the Oxford Levels of Evidence, we found that all the studies were Level I evidence. For the QUORUM assessment, we had 1 study with the highest score of 18. Additionally, we did the Oxman and Guyatt assessment, where we found 4 studies with a maximum score of 6. Finally, we did an AMSTAR assessment and found 2 studies with a score of 9. After conducting the methodological scores; the authors determined that Li. L et al 2021 had the highest quality. In addition, it was found that the CCA found among the primary studies in each systematic review calculated to .22. Any CCA above .15 is considered “very high overlap”. Conclusions The best available evidence suggests that Cemented HAs are better at preventing Prosthesis-related complications. Conversely, the best evidence also suggests that Cemented HA also results in longer operative time and increased intraoperative blood loss. When conducting future systematic reviews related to the topic, we ask that authors restrict conducting another systematic review until new evidence emerges so as not to confuse the clinical decision-making of physicians