The Variability of MCID, SCB, PASS, and MOI Thresholds for PROMs in the Reverse Total Shoulder Arthroplasty Literature: A Systematic Review.

BACKGROUND: Reverse total shoulder arthroplasty (RTSA) is a common procedure utilized to address degenerative pathologies of the glenohumeral joint and rotator cuff. Increased reliance on patient-reported outcome measures (PROMs) has placed emphasis on the utilization of the minimum clinically important difference (MCID), substantial clinical benefit (SCB), patient acceptable symptom state (PASS), and maximal outcome improvement (MOI) thresholds to assess the clinical efficacy of RTSA. In this study, we systematically reviewed the MCID, SCB, PASS, and MOI thresholds reported for PROMs following RTSA. METHODS: PubMed, Embase, MEDLINE, Cochrane Library, and Google Scholar were queried for articles from Jan. 1, 2000-Aug. 31, 2023 reporting MCID, SCB, PASS, or MOI values for PROMs following RTSA. Patient demographic data, study characteristics, MCID/SCB/PASS/MOI thresholds, and threshold calculation methods were extracted. RESULTS: 141 articles were screened with 39 ultimately included, comprising 11,984 total patients that underwent RTSA. 34 (87%) studies reported MCID thresholds, 20 (51%) reported SCB, 5 (13%) reported PASS, and 2 (5%) reported MOI. 25/39 (64%) studies referenced a previous study when reporting MCID, SCB, PASS, or MOI values, 11 (28%) used an anchor-based method to calculate threshold values, 1 (3%) used a distribution-based method, and 2 (5%) used both anchor and distribution methods. There were 19 newly calculated MCID (11), SCB (5), PASS (1), and MOI (2) thresholds. For five of the six most utilized PROMs (ASES, SST, Constant, UCLA, SPADI), the range of reported MCID values exceeded 50% of the most common threshold. For three of the six, the range of SCB values exceeded 25% of the most common threshold. CONCLUSION: There is substantial variability in the MCID and SCB threshold values reported in the RTSA literature. Standardizing the methodologic calculation and utilization of MCID, SCB, PASS, and MOI thresholds for RTSA may allow for improved assessment of PROMs.

The fragility of statistical findings in the reverse total shoulder arthroplasty literature: a systematic review of randomized controlled trials.

BACKGROUND: Reverse total shoulder arthroplasty (RTSA) has seen increasing utilization as an effective intervention for a wide variety of shoulder pathologies. The scope and indications for growth are often driven by findings from randomized controlled trials (RCTs) guiding surgical decision-making for RTSA. In this study, we utilized the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to assess the robustness of outcomes reported in RCTs in the RTSA literature. METHODS: PubMed, Embase, and MEDLINE were queried for RCTs (Jan. 1, 2010-Mar. 31, 2023) in the RTSA literature reporting dichotomous outcomes. The FI and rFI were defined as the number of outcome reversals required to alter statistical significance for significant and nonsignificant outcomes, respectively. The FQ was determined by dividing the FI by the sample size of each study. Subgroup analysis was performed based on outcome category. RESULTS: One hundred seventy-six RCTs were screened with 18 studies included. The median FI across 59 total outcomes was 4 (interquartile range [IQR]: 3-5) with an associated FQ of 0.051 (IQR: 0.029-0.065). Thirteen outcomes were statistically significant with a median FI of 3 (IQR: 1-4) and FQ of 0.033 (IQR: 0.012-0.066). Forty-six outcomes were nonsignificant with a median rFI of 4 (IQR: 3-5) and FQ of 0.055 (IQR: 0.032-0.065). The most fragile outcome category was revision/reoperations with a median FI of 2.50 (IQR: 1.00-3.25), followed by clinical score/outcome (median FI: 3.00), complications (median FI: 4.00), "other" (median FI: 4.00), and radiographic findings (median FI: 5.00). Notably, the number of patients lost to follow-up was greater than or equal to the FI for 59% of outcomes. CONCLUSION: The statistical findings in RTSA RCTs are fragile and should be interpreted with caution. Reversal of only a few outcomes, or maintaining postoperative follow-up, may be sufficient to alter significance of study findings. We recommend standardized reporting of P values with FI and FQ metrics to allow clinicians to effectively assess the robustness of study findings.

Statistical Outcomes Guiding Periprosthetic Joint Infection Prevention and Revision Are Fragile: A Systematic Review of Randomized Controlled Trials.

BACKGROUND: Dichotomous outcomes are frequently reported in orthopaedic research and have substantial clinical implications. This study utilizes the fragility index (FI) and fragility quotient (FQ) metrics to determine the statistical stability of outcomes reported in total joint arthroplasty randomized controlled trials (RCTs) relating to periprosthetic joint infection (PJI). METHODS: The RCTs that reported dichotomous data related to PJI published between January 1, 2010, and December 31, 2022, were evaluated. The FI and reverse FI (RFI) were defined as the number of outcome event reversals required to reverse the significance of significant and nonsignificant outcomes, respectively. The FQ was determined by dividing the FI or RFI by the respective sample size. There were 108 RCTs screened, and 17 studies included for analysis. RESULTS: A total of 58 outcome events were identified, with a median FI of 4 (interquartile range [IQR] 2 to 5) and associated FQ of 0.0417 (IQR 0.0145 to 0.0602). The 13 statistically significant outcomes had a median FI of 1 (IQR 1 to 2) and FQ of 0.00935 (IQR 0.00629 to 0.01410). The 45 nonsignificant outcomes had a median RFI of 4 (IQR 3 to 5) and FQ of 0.05 (IQR 0.0361 to 0.0723). The number of patients lost to follow-up was greater than or equal to the FI in 46.6% of outcomes. CONCLUSIONS: Statistical outcomes in RCTs analyzing PJI are fragile and may lack statistical integrity. We recommend a comprehensive fragility analysis, with the reporting of FI and FQ metrics, to aid in the interpretation of outcomes in the total joint arthroplasty literature.

Oral Postoperative Antibiotic Prophylaxis for Outpatient Total Hip and Knee Arthroplasty: Describing Current Practices.

BACKGROUND: Despite an increase in outpatient total hip arthroplasty (THA) and total knee arthroplasty (TKA), large-scale data are lacking on current practice for antibiotic prophylaxis prescribing. We aimed to describe current oral antibiotic prophylaxis practices nationally for outpatient THA and TKA. METHODS: This nationwide retrospective cohort study included primary outpatient THA or TKA procedures in patients aged 18 to 64 years from 2018 to 2021 using a national claims database. Oral antibiotic prescriptions filled perioperatively (defined as 5 days before to 3 days after surgery) were extracted; these were categorized and assumed to represent postoperative prophylaxis. Multivariable logistic regression measured associations between patient and surgery characteristics and perioperative oral antibiotic prophylaxis. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) are reported. RESULTS: Oral antibiotic prescriptions were filled in 16.5% of 73,015 outpatient THA and TKA (18.4% of 24,857 THAs, 15.5% of 48,158 TKAs) procedures. Prescriptions were most often for cephalosporins (74.3%), with cephalexin (52.8%), and cefadroxil (19.1%) being the most common. Non-cephalosporin antibiotics prescribed were mainly clindamycin (6.8%), sulfamethoxazole-trimethoprim (6.7%), and doxycycline (6.2%). The odds of receiving oral antibiotic prophylaxis were higher for THA compared to TKA (OR 1.13, 95% CI 1.09 to 1.18, P < .001) and in the presence of obesity, diabetes, and autoimmune conditions (OR 1.08 to 1.13, P < .001 to .01). Ambulatory surgery center procedures also had significantly increased odds of prophylaxis compared to hospital-based outpatient surgeries (OR 2.62, 95% CI 2.51 to 2.73, P < .001). Additionally, regional and time-based variations were noted. CONCLUSIONS: Perioperative oral antibiotic prophylaxis prescriptions were filled in only 16.5% of outpatient THA and TKA cases, with variation in the type of antibiotic prescribed. The receipt of any prophylaxis and specific medications was associated with demographic, clinical, and procedure-related characteristics. Follow-up research will evaluate associations with infection risk reduction.

Most cited articles involving lacrosse since 1990 primarily focus on concussion and traumatic brain injury.

OBJECTIVES: The purpose of this study was to identify the 50 most-cited publications relating to lacrosse since 1990 and conduct a bibliometric analysis of the identified studies. METHODS: Clarivate Analytics Web of Science database was queried to identify all publication titles, abstracts, and keywords for the term 'lacrosse' on 9 June 2023. The resulting articles were sorted by total number of citations. Titles and abstracts were included based on their relevance to lacrosse. Once the 50 most cited articles were identified, each article was further analyzed to obtain author name, publication year, country of origin, journal name, article type, research topic, competition level, total number of citations, and the level of evidence. Citation density (total number of citations/years since publication) was calculated and recorded for each of the most-cited studies. RESULTS: The 50 most-cited articles were cited 4237 of times with an average of 84 citations per article. The most cited article was cited 637 (15.0%) times. The articles came from 2 different countries, with the United States and Australia comprising 49 and 1 articles, respectively. All articles were published in English. The American Journal of Sports Medicine published the most articles (n = 21, 42.0%). The most studied topic was concussion/traumatic brain injury (n = 18) followed by studies assessing all injuries (n = 7). Collegiate-level lacrosse was the most studied level of competition (n = 22), while high school-level followed (n = 12). CONCLUSIONS: The majority of the 50 most-cited articles related to lacrosse since 1990 focus on the prevalence, diagnosis and identification of concussion/traumatic brain injury in high school and collegiate-level athletes. These articles are predominantly epidemiological or cohort studies with Level III or IV evidence that almost unanimously originate from the United States.

The Statistical Fragility of Marrow Stimulation for Cartilage Defects of the Knee: A Systematic Review of Randomized Controlled Trials.

OBJECTIVE: Marrow stimulation is used to address knee cartilage defects. In this study, we used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate statistical fragility of outcomes reported in randomized controlled trials (RCTs) evaluating marrow stimulation. DESIGN: PubMed, Embase, and MEDLINE were queried for recent RCTs (January 1, 2010-September 5, 2023) assessing marrow stimulation for cartilage defects of the knee. The FI and rFI were calculated as the number of outcome event reversals required to alter statistical significance for significant and nonsignificant outcomes, respectively. The FQ was determined by dividing the FI by the study sample size. RESULTS: Across 155 total outcomes from 21 RCTs, the median FI was 3 (interquartile range [IQR], 2-5), with an associated median FQ of 0.067 (IQR, 0.033-0.010). Thirty-two outcomes were statistically significant, with a median FI of 2 (IQR, 1-3.25) and FQ of 0.050 (IQR, 0.025-0.069). Ten of the 32 (31.3%) outcomes reported as statistically significant had an FI of 1. In total, 123 outcomes were nonsignificant, with a median rFI of 3 (IQR, 2-5). Studies assessing stem cell augments were the most fragile, with a median FI of 2. In 55.5% of outcomes, the number of patients lost to follow-up was greater than or equal to the FI. CONCLUSION: Statistical findings in RCTs evaluating marrow stimulation for cartilage defects of the knee are statistically fragile. We recommend combined reporting of P-values with FI and FQ metrics to aid in the interpretation of clinical findings in comparative trials assessing cartilage restoration.

Epidemiology and Sex-Specific Analysis of Basketball-Related Lower Extremity Fractures: A 10-Year Analysis of National Injury Data.

BACKGROUND: Basketball-related fractures involving the lower extremities frequently present to emergency departments (ED) in the United States (US). This study aimed to identify the primary mechanisms, distribution, and trends of these injuries. HYPOTHESIS: We hypothesize that (1) lower extremity fracture frequency will decrease from 2013 to 2022, (2) the ankle will be the most common fracture site, and (3) noncontact twisting will be the most common injury mechanism. STUDY DESIGN: Descriptive epidemiological. LEVEL OF EVIDENCE: Level 3. METHODS: The National Electronic Injury Surveillance System (NEISS) was queried for lower extremity fractures from basketball presenting to US EDs from January 1, 2013 to December 31, 2022. Patient demographics, injury location, and disposition were recorded. The injury mechanism was characterized using the provided narrative. National estimates (NEs) were calculated using the NEISS statistical sample weight. Injury trends were evaluated by linear regression. RESULTS: There were 6259 cases (NE: 185,836) of basketball-related lower extremity fractures. Linear regression analysis of annual trends demonstrated a significant decrease in lower extremity fractures over the study period (2013-2022: P = 0.01; R2 = 0.64). The most common injury mechanism was a noncontact twisting motion (NE: 49,897, 26.9%) followed by jumping (NE: 39,613, 21.3%). The ankle was the most common fracture site (NE: 69,936, 37.6%) followed by the foot (NE: 49,229, 26.49%). While ankle and foot fractures decreased significantly (P < 0.05), fractures of the lower leg, knee, toe, and upper leg showed no significant trends (P = 0.09, 0.75, 0.07, and 0.85, respectively). CONCLUSION: Basketball-related lower extremity fractures decreased from 2013 to 2022, with the ankle being the most common fracture site and most fractures arising from a noncontact twist. Increasing utilization of outpatient clinics may have contributed to the decline, particularly for ankle and foot fractures. The prevalence of ankle fractures and twisting-related injuries reinforces the importance of protective footwear and targeted strengthening protocols.

Skiing Injuries in the US Pediatric Population: An Analysis of National Injury Trends and Mechanisms Between 2012 and 2022.

Background: While prevention protocols have been implemented, skiing-related musculoskeletal injuries and concussions continue to present to emergency departments in the United States. Previous literature has suggested the pediatric population may constitute up to 40% of skiing-related injuries. Purpose: To assess injury trends and the underlying mechanisms of skiing injuries in pediatric patients seen at emergency departments in the United States. Study Design: Descriptive epidemiology study. Methods: The National Electronic Injury Surveillance System (NEISS) was queried for pediatric (age ≤18 years) skiing injuries between January 1, 2012, and December 31, 2022. Injury mechanism, location, disposition, and diagnosis were recorded, and the statistical sample weight assigned by NEISS by hospital was used to calculate national estimates (NEs). Injury trends were evaluated with linear regression analysis. Results: Overall, 2951 pediatric skiing injuries were included (NE = 123,386). The mean age of the patients was 12.4 ± 3.5 years, with 61.3% of the injuries occurring in male patients. Impact with the ground was the most common injury mechanism (NE = 87,407; 70.8%). Fractures were the most common diagnosis (NE = 38,527, 31.2%), followed by strains/sprains (NE = 22,562, 18.3%), contusions/abrasions (NE = 16,257, 13.2%), and concussions (NE = 12,449, 10.1%). The lower leg was the most common fracture site (NE = 9509, 24.7%), followed by the shoulder (NE = 7131, 18.5%) and lower arm (NE = 5876, 15.3%). Analysis of annual injuries revealed no significant trend between 2012 and 2022 (P = .17), with fluctuations apparent throughout the study period. Significant decreases were seen in strains/sprains (P < .01) and contusions/abrasions (P < .01), but not in concussions (P = .57) or fractures (P = .70). Conclusion: Impacts with the snow/ground made up 70.8% of all injuries. Fractures were the most common injury diagnosis, followed by strains/sprains, with the lower leg being most frequently fractured. While strains/sprains and contusions/abrasions showed a significant decline, there were no significant trends in fractures and concussions between 2012 and 2022.

The Fragility of Statistical Findings in the Femoral Neck Fracture Literature: A Systematic Review of Randomized Controlled Trials.

OBJECTIVES: Randomized controlled trials (RCTs) in the femoral neck fracture literature frequently report P -values for outcomes, which have substantial implications in guiding surgical management. This study used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to assess the statistical stability of outcomes reported in RCTs evaluating the management and treatment of femoral neck fractures. DESIGN: PubMed, Embase, and MEDLINE were queried for RCTs (January 1, 2010 to February 28, 2023). SETTING: RCTs that evaluated surgical management or treatment of femoral neck fractures were included. STUDY SELECTION CRITERIA: RCTs with 2 treatment arms reporting categorical dichotomous outcomes were included. Non-RCT studies, RCTs with greater than 2 treatment arms, and RCTs without a femoral neck fracture cohort were excluded. OUTCOME MEASURES AND COMPARISONS: The FI and rFI were calculated as the number of outcome event reversals required to alter statistical significance for significant ( P < 0.05) and nonsignificant ( P ≥ 0.05) outcomes, respectively. The FQ was calculated by dividing the FI by the sample size for the study. RESULTS: Nine hundred eighty-five articles were screened, with 71 studies included for analysis. The median FI across a total of 197 outcomes was 4 [interquartile range (IQR) 2-5] with an associated FQ of 0.033 (IQR 0.017-0.060). Forty-seven outcomes were statistically significant with a median FI of 2 (IQR 1-4) and associated FQ of 0.02 (IQR 0.014-0.043). One hundred fifty outcomes were statistically nonsignificant with a median rFI of 4 (IQR 3-5) and associated FQ of 0.037 (IQR 0.019-0.065). CONCLUSIONS: Statistical findings in femoral neck fracture RCTs are fragile, with reversal of a median 4 outcomes altering significance of study findings. The authors thus recommend standardized reporting of P -values with FI and FQ metrics to aid in interpreting the robustness of outcomes in femoral neck fracture RCTs. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

The Statistical Fragility of Tranexamic Acid Use in the Orthopaedic Surgery Literature: A Systematic Review of Randomized Controlled Trials.

INTRODUCTION: Randomized controlled trials (RCTs) represent the highest level of evidence in orthopaedic surgery literature, although the robustness of statistical findings in these trials may be unreliable. We used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate the statistical stability of outcomes reported in RCTs that assess the use of tranexamic acid (TXA) across orthopaedic subspecialties. METHODS: PubMed, EMBASE, and MEDLINE were queried for RCTs (2010-present) reporting dichotomous outcomes with study groups stratified by TXA administration. The FI and rFI were defined as the number of outcome event reversals needed to alter the significance level of significant and nonsignificant outcomes, respectively. FQ was determined by dividing the FI or rFI by sample size. Subgroup analyses were conducted based on orthopaedic subspecialty. RESULTS: Six hundred five RCTs were screened with 108 studies included for analysis comprising 192 total outcomes. The median FI of the 192 outcomes was 4 (IQR 2 to 5) with an associated FQ of 0.03 (IQR 0.019 to 0.050). 45 outcomes were reported as statistically significant with a median FI of 1 (IQR 1 to 5) and associated FQ of 0.02 (IQR 0.011 to 0.034). 147 outcomes were reported as nonsignificant with a median rFI of 4 (IQR 3 to 5) and associated FQ of 0.04 (IQR 0.023 to 0.051). The adult reconstruction, trauma, and spine subspecialties had a median FI of 4. Sports had a median FI of 3. Shoulder and elbow and foot and ankle had median FIs of 6. DISCUSSION: Statistical outcomes reported in RCTs on the use of TXA in orthopaedic surgery are fragile. Reversal of a few outcomes is sufficient to alter statistical significance. We recommend reporting FI, rFI, and FQ metrics to aid in interpreting the outcomes reported in comparative trials.

The statistical fragility of outcomes in calcaneus fractures: A systematic review of randomized controlled trials.

INTRODUCTION: The purpose of this study was to utilize the fragility index to assess the robustness of randomized controlled trials (RCTs) evaluating the management of calcaneus fractures. We hypothesize that the dichotomous outcomes in calcaneus fracture literature will be statistically fragile and comparable to other orthopedic specialties. METHODS: We performed a PubMed search for calcaneus fracture RCTs from 2000 to 2022 using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The fragility index (FI) of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient (FQ) was calculated by dividing each fragility index by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. RESULTS: Of the 3003 studies screened, 97 met the search criteria, with 19 RCTs evaluating calcaneus fractures included in the analysis. Seventy-nine dichotomous outcomes with 30 significant (P < 0.05) outcomes and 49 with nonsignificant (P> 0.05) outcomes were identified. The overall FI and FQ of all outcomes were 6 (IQR 3-8) and 0.067 (IQR 0.032-0.100), respectively. CONCLUSIONS: The literature surrounding calcaneus fractures may not be as statistically stable as previously thought. The sole reliance on the P value may depict misleading results. We, therefore, recommend reporting the P value in conjunction with the FI and FQ to give a robust contextualization of clinical findings in the calcaneus fracture literature.