Fragile Statistical Findings in Randomized Controlled Trials Evaluating Autograft Versus Allograft Use in Anterior Cruciate Ligament Reconstruction: A Systematic Review.

PURPOSE: To analyze the statistical stability of randomized controlled trials (RCTs) evaluating the surgical management of autografts versus allografts in the anterior cruciate ligament reconstruction (ACLR) literature and calculate the fragility index (FI) and fragility quotient and explore a subgroup analysis by calculating the proportion of outcome events where the FI was less than the number of patients lost to follow-up. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a systematic search in the PubMed and Cochrane databases to identify RCTs published between 2000 and 2022 that investigated the use of autografts versus allografts in ACLR literature and reported dichotomous data. The fragility index of each dichotomous variable was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient was calculated by dividing each fragility index by the study sample size. The interquartile range also was calculated. RESULTS: Of the 4407 articles screened, 23 met the search criteria, with 11 RCTs evaluating ALCR using autografts and allografts included for analysis. Two hundred and 18 outcome events with 32 significant (P < .05) outcomes and 186 nonsignificant (P ≥ .05) outcomes were identified. The overall fragility index and fragility quotient for all 218 outcomes were 6 subjects (interquartile range 5-8) and 0.058 (interquartile range 0.039-0.077). Fragility analysis of statistically significant outcomes and nonsignificant outcomes had a fragility index of 3.5 (interquartile range 1-5.5) and 6 (interquartile range 5-8), respectively. All of the studies reported a loss to follow-up where 45.5% (5) reported a loss to follow-up greater or equal to 6. CONCLUSIONS: The RCTs in the ACLR peer-reviewed literature evaluating autograft versus allograft use are vulnerable to a small number of outcome event reversals and exemplify significant statistical fragility in statistically significant findings. LEVEL OF EVIDENCE: Level I, systematic review of Level I studies.

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.

The fragility of statistical findings in distal biceps tendon repairs: a systematic review of randomized controlled trials.

BACKGROUND: The purpose of this present study was to perform a fragility analysis to assess the robustness of randomized controlled trials (RCTs) evaluating the distal biceps tendon repairs. We hypothesize that the dichotomous outcomes will be statistically fragile, and higher fragility will exist among statistically significant outcomes comparable to other orthopedic specialties. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), randomized controlled trials from 4 orthopedic journals indexed on PubMed from 2000 to 2022 reporting dichotomous measures relating to distal biceps tendon repairs were included. 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 1038 articles screened, 7 RCTs containing 24 dichotomous outcomes were included for analysis. The fragility index and fragility quotient of all outcomes was 6.5 (IQR 4-9) and 0.077 (IQR 0.031-0.123), respectively. However, statistically significant outcomes had a fragility index and fragility quotient of 2 (IQR 2-7) and 0.036 (IQR 0.025-0.091), respectively. The average number of patients lost to follow-up was 2.7 patients, with 28.6% of the included studies reporting loss to follow-up (LTF) greater than or equal to 6.5. CONCLUSIONS: The literature surrounding distal biceps tendon repair may not be as stable as previously thought and presents a similar fragility index to other orthopedic subspecialties. We therefore recommend triple reporting the P value, fragility index, and fragility quotient to aid in the interpretation of clinical findings reported in biceps tendon repair literature.

The Statistical Fragility of Orbital Fractures: A Systematic Review of Randomized Controlled Trials.

BACKGROUND: The P value has often been used as a tool to determine the statistical significance and evaluate the statistical robustness of study findings in orthopedic literature. The purpose of this study is to apply both the fragility index (FI) and the fragility quotient (FQ) to evaluate the degree of statistical fragility in orbital fracture literature. We hypothesized that the dichotomous outcomes within the orbital fracture literature will be vulnerable to a small number of outcome event reversals and will be statistically fragile. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), the authors identified all dichotomous data for randomized controlled trials (RCTs) in orbital fracture literature and performed a PubMed search from 2000 to 2022. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each FI by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. RESULTS: Of the 3,329 studies screened, 28 met the criteria with 10 RCTs evaluating orbital fractures included for analysis. A total of 58 outcome events with 22 significant (P < .05) outcomes and 36 nonsignificant (P ≥ .05) outcomes were identified. The overall FI and FQ for all 58 outcomes was 5 (IQR: 4 to 5) and 0.140 (IQR: 0.075 to 0.250), respectively. Fragility analysis of statistical significant outcomes and nonsignificant outcomes had an FI of 3.5 with no IQR and 5 (IQR 4-5), respectively. All of the studies reported a loss to follow-up data, where 20% (2) was greater than the overall FI of 5. CONCLUSION: The orbital fracture literature provides treatment guidance by relying on statistical significant results from RCTs. However, the RCTs in the orbital fracture peer-reviewed literature may not be statistically stable as previously thought. The sole reliance of the P value may depict misleading results. Thus, we recommend standardizing the reporting of the P value, FI, and FQ in the orbital fracture literature to aid readers in reliably drawing conclusions based on fragility outcome measures impacting clinical decision-making.

The statistical fragility of the distal fibula fracture literature: A systematic review of randomized controlled trials.

BACKGROUND: The purpose of this study was to apply both the fragility index (FI) and fragility quotient (FQ) to evaluate the degree of statistical fragility in the distal fibular fracture (DFF) literature. We hypothesized that the dichotomous outcomes within the DFF literature are statistically fragile. METHODS: We performed a PubMed search for distal fibular fractures clinical trials from 2000 to 2022 reporting dichotomous outcomes. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The 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 1158 articles screened, 23 met the search criteria, with six RCTs included for analysis. Forty-five outcome events with 5 significant (p < 0.05) outcomes and 40 nonsignificant (p ≥ 0.05) outcomes were identified. The overall FI and FQ was 5 (IQR 4-6) and 0.089 (IQR 0.061-0.107), respectively. CONCLUSIONS: The randomized controlled trials in the peer-reviewed distal fibular fracture literature may not be as robust as previously thought, as incorporating statistical analyses solely on a P value threshold is misleading. Standardized reporting of the P value, FI and FQ can help the clinician reliably draw conclusions based on the fragility of outcome measures.

The fragility of statistical significance in distal femur fractures: systematic review of randomized controlled trials.

PURPOSE: The purpose of this study was to apply both the fragility index (FI) and fragility quotient (FQ) to evaluate the degree of statistical fragility in the distal femur fracture (DFF) literature. We hypothesized that the dichotomous outcomes within the DFF literature are statistically fragile. METHODS: Using preferred reporting items for systematic reviews and meta-analyses, we performed a PubMed search for distal femur fractures clinical trials from 2000 to 2022 reporting dichotomous outcomes. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The 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 4258 articles screened, 92 met the search criteria, with eleven RCTs included for analysis. Ninety eight outcome events with 25 significant (P < 0.05) outcomes and 73 nonsignificant (P > 0.05) outcomes were identified. The overall FI and FQ for all 98 outcomes were 5 (IQR 4-6) and 0.130 (IQR 0.087-0.174), respectively. Three studies (33.3%) reported loss to follow (LTF) greater than 5. CONCLUSIONS: The randomized controlled trials in the peer-reviewed distal femur fracture literature may not be as robust as previously thought, as incorporating statistical analyses solely on a P value threshold is misleading. Standardized reporting of the P value, FI and FQ can help the clinician reliably draw conclusions based on the fragility of outcome measures.